Regulation Text
(a) Identification. A diagnostic muscle stimulator is a device used mainly with an electromyograph machine to initiate muscle activity. It is intended for medical purposes, such as to diagnose motor nerve or sensory neuromuscular disorders and neuromuscular function.
(b) Classification. Class II (performance standards).
Authority
21 U.S.C. 351,360,360c,360e,360j,360l,371.