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Stimulator, Muscle, Powered, For Muscle Conditioning

FDA product code NGX · 148 cleared devices

Class 2 Physical Medicine
Regulation
21 CFR 890.5850
Review panel
PM
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2001-09-27 – 2026-08-13

A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatigue resistance. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this device is not intended for use in patients with medical conditions and is intended only for muscle conditioning purposes.

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