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: Transtek Glass Body Analyzer, Model: GBF-830, GBF-835, GBF-950, and SA-15. 4. Comparison device: Scaleman Body Fat Scales, FS-148BW1 (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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Verify the accuracy of measure functions of device
Timeframe: 10 days