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Clinical Trail of Transtek Glass Body Fat Analyzer
The clinical protocol of the clinical testing of this device: 1. Objective of the test: To verify the functions and efficiency of devices. 2. Test methods and procedures: Comparison Test. 3. DUT(Device Under Test): Transtek Glass Body Fat Analyzer, Model: GBF-733-W1, GBF-1012, BF-1039, BF-1041-A, and GBF-950-D. 4. Comparison device: Transtek Glass Body Analyzer, GBF-950 (Predicate Device). 5. Study endpoints: Transtek devices and the predicate device are substantial equivalence. 6. Statistical methodology used: Description of statistical methods. 7. Result: Efficiencies of Transtek devices and predicate device are in the same level.
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