[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR890.1850]

[Page 489-490]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 890--PHYSICAL MEDICINE DEVICES--Table of Contents
 
             Subpart B--Physical Medicine Diagnostic Devices
 
Sec. 890.1850  Diagnostic muscle stimulator.

    (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.

[[Page 490]]

    (b) Classification. Class II (performance standards).