[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR890.1385]

[Page 499]
 
                        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. 890.1385  Diagnostic electromyograph needle electrode.

    (a) Identification. A diagnostic electromyograph needle electrode is 
a monopolar or bipolar needle intended to be inserted into muscle or 
nerve tissue to sense bioelectrical signals. The device is intended for 
medical purposes for use in connection with electromyography (recording 
the intrinsic electrical properties of skeletal muscle).
    (b) Classification. Class II (performance standards).