Regulation Text
(a) Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.
(b) Classification. Class II (performance standards).
Authority
21 U.S.C. 351,360,360c,360e,360j,360l,371.
Related Warning Letters (1)
- 2023-11-07
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
Neurotris, Inc. dba A1 Engineering