[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: 21CFR890.1375]

[Page 489]
 
                        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. 890.1375  Diagnostic electromyograph.

    (a) Identification. A diagnostic electromyograph is a device 
intended for medical purposes, such as to monitor and display the 
bioelectric signals produced by muscles, to stimulate peripheral nerves, 
and to monitor and display the electrical activity produced by nerves, 
for the diagnosis and prognosis of neuromuscular disease.
    (b) Classification. Class II (performance standards).