PART 890—PHYSICAL MEDICINE DEVICES Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, Source: 48 FR 53047, Nov. 23, 1983, unless otherwise noted. Editorial Note: Nomenclature changes to part 890 appear at 73 FR 35341, June 23, 2008. Subpart A—General Provisions § 890.1 Scope. (a) This part sets forth the classification of physical medicine devices intended for human use that are in commercial distribution. (b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under part 807 may not show merely that the device is accurately described by the section title and identification provisions of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required by § 807.87. (c) To avoid duplicative listings, a physical medicine device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic device) is listed only in one subpart. (d) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted. (e) Guidance documents referenced in this part are available on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm.. [52 FR 17741, May 11, 1987, as amended at 73 FR 34860, June 19, 2008; 78 FR 18233, Mar. 26, 2013] § 890.3 Effective dates of requirement for premarket approval. A device included in this part that is classified into class III (premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer has an approval under section 515 of the act (unless an exemption has been granted under section 520(g)(2) of the act). An approval under section 515 of the act consists of FDA's issuance of an order approving an application of premarket approval (PMA) for the device or declaring completed a product development protocol (PDP) for the device. (a) Before FDA requires that a device commercially distributed before the enactment date of the amendments, or a device that has been found substantially equivalent to such a device, has an approval under section 515 of the act FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as provided in paragraph (b) of this section. Such a regulation under section 515(b) of the act shall not be effective during the grace period ending on the 90th day after its promulgation or on the last day of the 30th full calendar month after the regulation that classifies the device into class III is effective, whichever is later. See section 501(f)(2)(B) of the act. Accordingly, unless an effective date of the requirement for premarket approval is shown in the regulation for a device classified into class III in this part, the device may be commercially distributed without FDA's issuance of an order approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act requiring premarket approval for a device, section 501(f)(1)(A) of the act applies to the device. (b) Any new, not substantially equivalent, device introduced into commercial distribution on or after May 28, 1976, includiing a device formerly marketed that has been substantially altered, is classified by statute (section 513(f) of the act) into class III without any grace period and FDA must have issued an order approving a PMA or declaring completed a PDP for the device before the device is commercially distributed unless it is reclassified. If FDA knows that a device being commercially distributed may be a “new” device as defined in this section because of any new intended use or other reasons, FDA may codify the statutory classification of the device into class III for such new use. Accordingly, the regulation for such a class III device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution. [52 FR 17741, May 11, 1987] § 890.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when: (a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only; (b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or (c) The device is an in vitro device that is intended: (1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism; (3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy; (4) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a microorganism directly from clinical material; (7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma; (8) For noninvasive testing as defined in § 812.3(k) of this chapter; and (9) For near patient testing (point of care). [65 FR 2321, Jan. 14, 2000] Subpart B—Physical Medicine Diagnostic Devices § 890.1175 Electrode cable. (a) Identification. (b) Classification. (1) The performance standard under part 898 of this chapter, and (2) The guidance document entitled “Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables.” This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to § 890.9. [48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63014, Dec. 7, 1994; 65 FR 19319, Apr. 11, 2000] § 890.1225 Chronaximeter. (a) Identification. (b) Classification. § 890.1375 Diagnostic electromyograph. (a) Identification. (b) Classification. § 890.1385 Diagnostic electromyograph needle electrode. (a) Identification. (b) Classification. § 890.1450 Powered reflex hammer. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019] § 890.1575 Force-measuring platform. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38816, July 25, 2001] § 890.1600 Intermittent pressure measurement system. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38816, July 25, 2001] § 890.1615 Miniature pressure transducer. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38816, July 25, 2001] § 890.1850 Diagnostic muscle stimulator. (a) Identification. (b) Classification. § 890.1925 Isokinetic testing and evaluation system. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59230, Nov. 3, 1998] Subpart C [Reserved] Subpart D—Physical Medicine Prosthetic Devices § 890.3025 Prosthetic and orthotic accessory. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001; 90 FR 55993, Dec. 4, 2025] § 890.3050 External compression device for internal jugular vein compression. (a) Identification. (b) Classification. (1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Performance testing must demonstrate that the device performs as intended under anticipated conditions of use for the duration of the labeled use life. (3) Human factors and usability testing must demonstrate that users can correctly use the device, including the user's ability to correctly determine device size and confirm the proper fit of the device. Users must understand product limitations, warnings, and precautions, including the warning that the device does not prevent head injury and medical treatment should be sought following head injury. (4) Labeling must include the following: (i) A warning that the device does not replace, and should be worn with, other protective sports equipment associated with specific sports activities, such as helmets and shoulder pads; (ii) A warning that the device should not be worn if it interferes with other existing protective equipment; (iii) A warning that users should avoid head and neck impacts to the extent possible; (iv) A warning that serious harm can result from persistent, excessive pressure on the neck due to incorrect device size and fit; and (v) A warning that the device has not been demonstrated to prevent long-term cognitive function deficits, and the ultimate impact on clinical outcomes has not been evaluated. [89 FR 71160, Sept. 3, 2024] § 890.3075 Cane. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001; 90 FR 55993, Dec. 4, 2025] § 890.3100 Mechanical chair. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63014, Dec. 7, 1994; 66 FR 38816, July 25, 2001] § 890.3110 Electric positioning chair. (a) Identification. (b) Classification. (1) Appropriate analysis and non-clinical testing must demonstrate that the safety controls are adequate to ensure safe use of the device and prevent user falls from the device in the event of a device failure; (2) Appropriate analysis and non-clinical testing must demonstrate the ability of the device to withstand the rated user weight load with an appropriate factor of safety; (3) Appropriate analysis and non-clinical testing must demonstrate the longevity of the device to withstand external forces applied to the device and provide the user with an expected service life of the device; (4) Appropriate analysis and non-clinical testing must demonstrate proper environments of use and storage of the device to maximize the longevity of the device; (5) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of ANSI/AAMI/ES60601-1, “Medical Electrical Equipment—Part 1: General Requirements for Basic Safety and Essential Performance,” and ANSI/AAMI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Basic Safety and Essential Performance—Collateral Standard: Electromagnetic Disturbances—Requirements and Tests”) must validate electromagnetic compatibility and electrical safety; (6) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of ANSI/AAMI/ISO 10993-1, “Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing Within a Risk Management Process,” ANSI/AAMI/ISO 10993-5, “Biological Evaluation of Medical Devices—Part 5: Tests for In Vitro Cytotoxicity,” and ANSI/AAMI/ISO 10993-10, “Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Skin Sensitization”) must validate that the skin-contacting components of the device are biocompatible; (7) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of IEC 62304, “Medical Device Software—Software Life Cycle Processes”) must validate the software life cycle and that all processes, activities, and tasks are implemented and documented; (8) Appropriate analysis and non-clinical testing must validate that the device components are found to be non-flammable; (9) Appropriate analysis and non-clinical testing must validate that the battery in the device (if applicable) performs as intended over the anticipated service life of the device; and (10) Adequate patient labeling is provided to the user to document proper use and maintenance of the device to ensure safe use of the device by the patient in the intended use environment. [48 FR 53047, Nov. 23, 1983, as amended at 80 FR 72950, Nov. 20, 2015] § 890.3150 Crutch. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001; 90 FR 55993, Dec. 4, 2025] § 890.3175 Flotation cushion. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38816, July 25, 2001] § 890.3410 External limb orthotic component. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001; 90 FR 55994, Dec. 4, 2025] § 890.3420 External limb prosthetic component. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001; 90 FR 55994, Dec. 4, 2025] § 890.3450 Upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components. (a) Identification. (b) Classification. (1) Appropriate analysis/testing must validate electronic compatibility, electrical safety, thermal safety, mechanical safety, battery performance and safety, and wireless performance, if applicable. (2) Appropriate software verification, validation, and hazard analysis must be performed. (3) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must include: (i) Mechanical bench data, including durability testing, to demonstrate that the device will withstand forces, conditions, and environments encountered during use. (ii) Simulated use testing to demonstrate performance of arm commands and available safeguard(s) under worst case conditions and after durability testing. (iii) Verification and validation of force sensors and hand release button, if applicable, are necessary. (iv) Device functionality in terms of flame retardant materials, liquid/particle ingress prevention, sensor and actuator performance, and motor and brake performance. (v) The accuracy of the device features and safeguards. (4) Non-clinical and clinical performance testing must demonstrate the accuracy of device features and safeguards. (5) Elements of the device that may contact the patient must be demonstrated to be biocompatible. (6) Documented clinical experience and human factors testing must demonstrate safe and effective use, capture any adverse events observed during clinical use and demonstrate the accuracy of device features and safeguards. (7) Labeling for the Prosthetist and User Guide must include: (i) Appropriate instructions, warning, cautions, limitations, and information related to the necessary safeguards of the device, including warning against activities that may put the user at greater risk ( e.g., (ii) Specific instructions and the clinical training needed for the safe use of the device, which includes: (A) Instructions on assembling the device in all available configurations, (B) Instructions on fitting the patient, (C) Instructions and explanations of all available programs and how to program the device, (D) Instructions and explanation of all controls, input, and outputs, (E) Instructions on all available modes or states of the device, (F) Instructions on all safety features of the device, and (G) Instructions for maintaining the device. (iii) Information on the patient population for which the device has been demonstrated to be effective. (iv) A detailed summary of the non-clinical and clinical testing pertinent to use of the device. [81 FR 71612, Oct. 18, 2016] § 890.3475 Limb orthosis. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001; 90 FR 55994, Dec. 4, 2025] § 890.3480 Powered lower extremity exoskeleton. (a) Identification. (b) Classification. (1) Elements of the device materials that may contact the patient must be demonstrated to be biocompatible. (2) Appropriate analysis/testing must validate electromagnetic compatibility/interference (EMC/EMI), electrical safety, thermal safety, mechanical safety, battery performance and safety, and wireless performance, if applicable. (3) Appropriate software verification, validation, and hazard analysis must be performed. (4) Design characteristics must ensure geometry and materials composition are consistent with intended use. (5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must include: (i) Mechanical bench testing (including durability testing) to demonstrate that the device will withstand forces, conditions, and environments encountered during use; (ii) Simulated use testing ( i.e., (iii) Verification and validation of manual override controls are necessary, if present; (iv) The accuracy of device features and safeguards; and (v) Device functionality in terms of flame retardant materials, liquid/particle ingress prevention, sensor and actuator performance, and motor performance. (6) Clinical testing must demonstrate a reasonable assurance of safe and effective use and capture any adverse events observed during clinical use when used under the proposed conditions of use, which must include considerations for: (i) Level of supervision necessary, and (ii) Environment of use ( e.g., (7) A training program must be included with sufficient educational elements so that upon completion of training program, the clinician, user, and companion can: (i) Identify the safe environments for device use, (ii) Use all safety features of device, and (iii) Operate the device in simulated or actual use environments representative of indicated environments and use. (8) Labeling for the Physician and User must include the following: (i) Appropriate instructions, warning, cautions, limitations, and information related to the necessary safeguards of the device, including warning against activities and environments that may put the user at greater risk. (ii) Specific instructions and the clinical training needed for the safe use of the device, which includes: (A) Instructions on assembling the device in all available configurations; (B) Instructions on fitting the patient; (C) Instructions and explanations of all available programs and how to program the device; (D) Instructions and explanation of all controls, input, and outputs; (E) Instructions on all available modes or states of the device; (F) Instructions on all safety features of the device; and (G) Instructions for properly maintaining the device. (iii) Information on the patient population for which the device has been demonstrated to have a reasonable assurance of safety and effectiveness. (iv) Pertinent non-clinical testing information ( e.g., (v) A detailed summary of the clinical testing including: (A) Adverse events encountered under use conditions, (B) Summary of study outcomes and endpoints, and (C) Information pertinent to use of the device including the conditions under which the device was studied ( e.g., e.g., [80 FR 25529, May 4, 2015] § 890.3490 Truncal orthosis. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001; 90 FR 55994, Dec. 4, 2025] § 890.3500 External assembled lower limb prosthesis. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998] § 890.3520 Plinth. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817, July 25, 2001; 90 FR 55994, Dec. 4, 2025] § 890.3610 Rigid pneumatic structure orthosis. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987; 61 FR 50711, Sept. 27, 1996] § 890.3640 Arm sling. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817, July 25, 2001; 90 FR 55994, Dec. 4, 2025] § 890.3665 Congenital hip dislocation abduction splint. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817, July 25, 2001; 90 FR 55994, Dec. 4, 2025] § 890.3675 Denis Brown splint. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817, July 25, 2001; 90 FR 55994, Dec. 4, 2025] § 890.3690 Powered wheeled stretcher. (a) Identification. (b) Classification. (1) Appropriate analysis and nonclinical testing must demonstrate that the safety controls are adequate to ensure safe use of the device and prevent user falls from the device in the event of a device failure; (2) Appropriate analysis and nonclinical testing must demonstrate the ability of the device to withstand the rated user weight load with an appropriate factor of safety; (3) Appropriate analysis and nonclinical testing must demonstrate the longevity of the device to withstand external forces applied to the device and provide the user with an expected service life of the device; (4) Appropriate analysis and nonclinical testing must demonstrate proper environments of use and storage of the device to maximize the longevity of the device; (5) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate electromagnetic compatibility and electrical safety; (6) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate that the skin-contacting components of the device are biocompatible; (7) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate the software life cycle and that all processes, activities, and tasks are implemented and documented; (8) Appropriate analysis and nonclinical testing must validate that the device components are found to be nonflammable; (9) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate that the battery in the device performs as intended over the anticipated service life of the device; (10) Adequate labeling is provided to the user to document proper use and maintenance of the device to ensure safe use of the device in the intended use environment; and (11) Appropriate risk assessment including, but not limited to, evaluating the dimensional limits of the gaps in hospital beds, and mitigation strategy to reduce entrapment. [48 FR 53047, Nov. 23, 1983, as amended at 85 FR 2020, Jan. 14, 2020] § 890.3700 Nonpowered communication system. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 54 FR 25052, June 12, 1989; 66 FR 38817, July 25, 2001; 90 FR 55994, Dec. 4, 2025] § 890.3710 Powered communication system. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998] § 890.3725 Powered environmental control system. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998] § 890.3750 Mechanical table. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63014, Dec. 7, 1994; 66 FR 38817, July 25, 2001] § 890.3760 Powered table. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38817, July 25, 2001] § 890.3790 Cane, crutch, and walker tips and pads. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817, July 25, 2001; 90 FR 55994, Dec. 4, 2025] § 890.3800 Motorized three-wheeled vehicle. (a) Identification. (b) Classification. § 890.3825 Mechanical walker. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817, July 25, 2001; 90 FR 55994, Dec. 4, 2025] § 890.3850 Mechanical wheelchair. (a) Identification. (b) Classification. § 890.3860 Powered wheelchair. (a) Identification. (b) Classification. § 890.3880 Special grade wheelchair. (a) Identification. (b) Classification. § 890.3890 Stair-climbing wheelchair. (a) Identification. (b) Classification. (1) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use. (2) Performance testing must demonstrate adequate mechanical performance under simulated use conditions and environments. Performance testing must include the following: (i) Fatigue testing; (ii) Resistance to dynamic loads (impact testing); (iii) Effective use of the braking mechanism and how the device stops in case of an electrical brake failure; (iv) Demonstration of adequate stability of the device on inclined planes (forward, backward, and lateral); (v) Demonstration of the ability of the device to safely ascend and descend obstacles (i.e., stairs, curb); and (vi) Demonstration of ability to effectively use the device during adverse temperatures and following storage in adverse temperatures and humidity conditions. (3) The skin-contacting components of the device must be demonstrated to be biocompatible. (4) Software design, verification, and validation must demonstrate that the device controls, alarms, and user interfaces function as intended. (5) Appropriate analysis and performance testing must be conducted to verify electrical safety and electromagnetic compatibility of the device. (6) Performance testing must demonstrate battery safety and evaluate longevity. (7) Performance testing must evaluate the flammability of device components. (8) Patient labeling must bear all information required for the safe and effective use of the device, specifically including the following: (i) A clear description of the technological features of the device and the principles of how the device works; (ii) A clear description of the appropriate use environments/conditions, including prohibited environments; (iii) Preventive maintenance recommendations; (iv) Operating specifications for proper use of the device such as patient weight limitations, device width, and clearance for maneuverability; and (v) A detailed summary of the device-related adverse events and how to report any complications. (9) Clinician labeling must include all the information in the Patient labeling noted in paragraph (b)(8) of this section but must also include the following: (i) Identification of patients who can effectively operate the device; and (ii) Instructions on how to fit, modify, or calibrate the device. (10) Usability studies of the device must demonstrate that the device can be used by the patient in the intended use environment with the instructions for use and user training. [79 FR 20782, Apr. 14, 2014] § 890.3900 Standup wheelchair. (a) Identification. (b) Classification. § 890.3910 Wheelchair accessory. (a) Identification. (b) Classification. [61 FR 8439, Mar. 4, 1996, as amended at 66 FR 38817, July 25, 2001; 90 FR 55994, Dec. 4, 2025] § 890.3920 Wheelchair component. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63014, Dec. 7, 1994; 66 FR 38817, July 25, 2001] § 890.3930 Wheelchair elevator. (a) Permanently mounted wheelchair platform lift Identification. (2) Classification. (i) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate that the safety controls are adequate to prevent a free fall of the platform in the event of a device failure; (ii) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate the ability of the device to withstand the rated load with an appropriate factor of safety; (iii) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate the ability of the enclosures to prevent the user from falling from the device; and (iv) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized editions of AAMI/ANSI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests,” and ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must validate electromagnetic compatibility and electrical safety. (b) Portable wheelchair elevators Identification. (2) Classification. [78 FR 14015, Mar. 4, 2013] § 890.3940 Wheelchair platform scale. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63015, Dec. 7, 1994; 66 FR 38817, July 25, 2001; 90 FR 55995, Dec. 4, 2025] Subpart E [Reserved] Subpart F—Physical Medicine Therapeutic Devices § 890.5050 Daily activity assist device. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817, July 25, 2001; 90 FR 55995, Dec. 4, 2025] § 890.5100 Immersion hydrobath. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019] § 890.5110 Paraffin bath. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019] § 890.5125 Nonpowered sitz bath. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 54 FR 25052, June 12, 1989; 66 FR 38818, July 25, 2001; 90 FR 55995, Dec. 4, 2025] § 890.5150 Powered patient transport. (a) Powered patient stairway chair lifts Identification. (2) Classification. (i) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of American Society of Mechanical Engineers (ASME) A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate that the safety controls are adequate to prevent a free fall of the chair in the event of a device failure; (ii) Appropriate analysis and nonclinical testing must demonstrate the ability of the device, including armrests, to withstand the rated load with an appropriate factor of safety; (iii) Appropriate restraints must be provided to prevent the user from falling from the device (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”); (iv) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized editions of AAMI/ANSI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests,” and ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must validate electromagnetic compatibility and electrical safety; and (v) Appropriate analysis and nonclinical testing must demonstrate the resistance of the device upholstery to ignition. (b) All other powered patient transport Identification. (2) Classification. [78 FR 14017, Mar. 4, 2013] § 890.5160 Air-fluidized bed. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998] § 890.5170 Powered flotation therapy bed. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998] § 890.5180 Manual patient rotation bed. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1963, as amended at 65 FR 2322, Jan. 14, 2000] § 890.5225 Powered patient rotation bed. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998] § 890.5250 Moist steam cabinet. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019] § 890.5275 Microwave diathermy. (a) Microwave diathermy for use in applying therapeutic deep heat for selected medical conditions Identification. (2) Classification. (b) Microwave diathermy for all other uses Identification. (2) Classification. (c) Date PMA or notice of completion of PDP is required. [48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987; 64 FR 18331, Apr. 14, 1999] § 890.5290 Shortwave diathermy. (a) Shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions Identification. (2) Classification. (b) Nonthermal shortwave therapy Identification. (2) Classification: Class II (special controls). (i) Components of the device that come into human contact must be demonstrated to be biocompatible. (ii) Appropriate analysis/testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment. (iii) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Non-clinical performance testing must characterize the output waveform of the device and demonstrate that the device meets appropriate output performance specifications. The output characteristics and the methods used to determine these characteristics, including the following, must be determined: (A) Peak output power; (B) Pulse width; (C) Pulse frequency; (D) Duty cycle; (E) Characteristics of other types of modulation that may be used; (F) Average measured output powered into the RF antenna/applicator; (G) Specific absorption rates in saline gel test load or other appropriate model; (H) Characterization of the electrical and magnetic fields in saline gel test load or other appropriate model for each RF antenna and prescribed RF antenna orientation/position; and (I) Characterization of the deposited energy density in saline gel test load or other appropriate model. (iv) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device in its intended use. (v) Labeling must include the following: (A) Output characteristics of the device; (B) Recommended treatment regimes, including duration of use; and (C) A detailed summary of the clinical testing pertinent to the use of the device and a summary of the adverse events and complications. (vi) Nonthermal shortwave therapy devices marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with these special controls. [48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987; 80 FR 61302, Oct. 13, 2015] § 890.5300 Ultrasonic diathermy. (a) Ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions Identification. (2) Classification. (b) Ultrasonic diathermy for all other uses Identification. (2) Classification. (c) Date PMA or notice of completion of PDP is required. [48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987; 64 FR 18331, Apr. 14, 1999] § 890.5350 Exercise component. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38818, July 25, 2001; 90 FR 55995, Dec. 4, 2025] § 890.5360 Measuring exercise equipment. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019; 85 FR 44188, July 22, 2020] § 890.5370 Nonmeasuring exercise equipment. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38818, July 25, 2001; 90 FR 55995, Dec. 4, 2025] § 890.5380 Powered exercise equipment. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38818, July 25, 2001] § 890.5410 Powered finger exerciser. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38818, July 25, 2001] § 890.5420 Electroencephalography (EEG)-driven upper extremity powered exerciser. (a) Identification. (b) Classification. (1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must capture any adverse events observed during clinical use and must demonstrate that the EEG signal can be translated into intended motion. (2) Software verification, validation, and hazard analysis must be performed. (3) Performance data must demonstrate the electromagnetic compatibility, electrical safety, battery safety, and wireless compatibility of the device. (4) The device components that contact the patient must be demonstrated to be biocompatible. (5) Performance data must validate the reprocessing instructions for the reusable components of the device. (6) Labeling must include: (i) Instructions on fitting the device to the patient; (ii) Information on how the device operates and the typical sensations experienced during treatment; and (iii) Reprocessing instructions. [88 FR 983, Jan. 6, 2023] § 890.5500 Infrared lamp. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019] § 890.5525 Iontophoresis device. (a) Iontophoresis device intended for certain specified uses Identification. (2) Classification. (b) Iontophoresis device intended for any other purposes Identification. (2) Classification. (i) The following performance testing must be conducted: (A) Testing using a drug approved for iontophoretic delivery, or a solution if identified in the labeling, to demonstrate safe use of the device as intended; (B) Testing of the ability of the device to maintain a safe pH level; and (C) If used in the ear, testing of the device to demonstrate mechanical safety. (ii) Labeling must include adequate instructions for use, including sufficient information for the health care provider to determine the device characteristics that affect delivery of the drug or solution and to select appropriate drug or solution dosing information for administration by iontophoresis. This includes the following: (A) A description and/or graphical representation of the electrical output; (B) A description of the electrode materials and pH buffer; (C) When intended for general drug delivery, language referring the user to drug labeling approved for iontophoretic delivery to determine if the drug they intend to deliver is specifically approved for use with that type of device and to obtain relevant dosing information; and (D) A detailed summary of the device-related and procedure-related complications pertinent to use of the device, and appropriate warnings and contraindications, including the following warning: Warning: (iii) Appropriate analysis/testing must demonstrate electromagnetic compatibility, electrical safety, thermal safety, and mechanical safety. (iv) Appropriate software verification, validation, and hazard analysis must be performed. (v) The elements of the device that may contact the patient must be demonstrated to be biocompatible. (vi) The elements of the device that may contact the patient must be assessed for sterility, for devices labeled as sterile. (vii) Performance data must support the shelf life of the elements of the device that may be affected by aging by demonstrating continued package integrity and device functionality over the stated shelf life. [48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987; 81 FR 48706, July 26, 2016; 83 FR 13864, Apr. 2, 2018] § 890.5575 Powered external limb overload warning device. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019] § 890.5650 Powered inflatable tube massager. (a) Identification. (b) Classification. § 890.5660 Therapeutic massager. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38818, July 25, 2001] § 890.5670 Internal therapeutic massager. (a) Identification. (b) Classification. (1) Labeling must include adequate directions for use. (2) Non-clinical performance testing must demonstrate electromagnetic compatibility (EMC), electrical safety and mechanical safety. (3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Mechanical durability; and (ii) Accuracy of the feedback mechanism. (4) Software verification, validation, and hazard analysis must be performed. (5) The patient-contacting components of the device must be demonstrated to be biocompatible. [84 FR 57323, Oct. 25, 2019, as amended at 85 FR 44188, July 22, 2020] § 890.5700 Cold pack. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 90 FR 55995, Dec. 4, 2025] § 890.5710 Hot or cold disposable pack. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1963, as amended at 65 FR 2322, Jan. 14, 2000] § 890.5720 Water circulating hot or cold pack. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998] § 890.5730 Moist heat pack. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38818, July 25, 2001; 90 FR 55995, Dec. 4, 2025] § 890.5740 Powered heating pad. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998] § 890.5760 Nonpowered lower extremity pressure wrap. (a) Identification. (b) Classification. [79 FR 37950, July 3, 2014] § 890.5765 Pressure-applying device. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63015, Dec. 7, 1994; 66 FR 38818, July 25, 2001] § 890.5800 Virtual reality behavioral therapy device for pain relief. (a) Identification. (b) Classification. (1) Clinical performance testing under the labeled conditions for use must validate the model of behavioral therapy as implemented by the device and evaluate all adverse events. (2) The patient-contacting components of the device must be demonstrated to be biocompatible. (3) Software verification, validation, and hazard analysis must be performed. (4) Electromagnetic compatibility and electrical, mechanical, and thermal safety testing must be performed. (5) Labeling must include the following: (i) A warning regarding the risk of nausea and motion sickness; (ii) A warning regarding the risk of discomfort from the device; and (iii) A summary of the clinical testing with the device. [88 FR 985, Jan. 6, 2023] § 890.5850 Powered muscle stimulator. (a) Identification. (b) Classification. § 890.5860 Ultrasound and muscle stimulator. (a) Ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions Identification. (2) Classification. (b) Ultrasound and muscle stimulator for all other uses Identification. (2) Classification. (c) Date PMA or notice of completion of PDP is required. [48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987; 64 FR 18331, Apr. 14, 1999] § 890.5870 Non-invasive bone growth stimulator. (a) Identification. (b) Classification. (1) Clinical data must demonstrate that the device performs as intended under anticipated conditions of use. Imaging data must demonstrate fusion at the treatment site. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Critical performance and safety characteristics of the device, considering the operational modality of the device, must be verified and validated to ensure: (i) Intended design outputs are delivered to the patient; (ii) Thermal safety and thermal reliability; (iii) Signal characteristics are within safe physiologic limits; and (iv) Device reliability is consistent with the expected use-life. (3) Patient-contacting components of the device must be demonstrated to be biocompatible. (4) Performance data must demonstrate the electrical safety and electromagnetic compatibility of the device. (5) Appropriate software verification, validation, and hazard analysis must be performed. (6) Labeling comprehension testing must demonstrate the patient can correctly use the device based solely on reading the instructions for use. (7) Labeling for the device must include the following: (i) Warning against use on compromised skin or when there are known skin sensitivities; (ii) Appropriate warnings for patients with implanted medical devices; (iii) A detailed summary of the supporting clinical data, which includes the clinical outcomes associated with the use of the device, and a summary of adverse events and complications that occurred with the device; (iv) A clear description of the device; (v) Instructions on appropriate usage, duration, and frequency of use; (vi) Instructions for maintenance and safe disposal; (vii) Validated instructions for appropriate cleaning of any reusable components; (viii) Specific warnings regarding user burns, electrical shock, and skin irritation; and (ix) The risks and benefits associated with use of the device when used as intended. [91 FR 20362, Apr. 16, 2026] § 890.5880 Multi-function physical therapy table. (a) Identification. (b) Classification. § 890.5900 Power traction equipment. (a) Identification. (b) Classification. § 890.5925 Traction accessory. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38818, July 25, 2001; 90 FR 55995, Dec. 4, 2025] § 890.5940 Chilling unit. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38818, July 25, 2001] § 890.5950 Powered heating unit. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38818, July 25, 2001] § 890.5975 Therapeutic vibrator. (a) Identification. (b) Classification. [48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38818, July 25, 2001]