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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator, muscle, powered, with limited output, for muscle conditioning
Regulation Description Powered muscle stimulator.
Definition Used for muscle stimulation for muscle conditioning. Device repeatedly contracts muscles by passing pulsed electrical current through cutaneous electrodes and into the body. Temporarily affects the stimulated muscles contractile properties, force output, and/or fatigue resistance. Not intended to be used for medical purposes (e.g., rehabilitation), for aesthetic purposes (e.g., changing the physical appearance of the muscle or body), or for the purpose of improving athletic performance.
Product CodeNYZ
Regulation Number 890.5850
Device Class 2