[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: 21CFR882.1700]

[Page 406-407]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 882--NEUROLOGICAL DEVICES--Table of Contents
 
               Subpart B--Neurological Diagnostic Devices
 
Sec. 882.1700  Percussor.

    (a) Identification. A percussor is a small hammerlike device used by 
a physician to provide light blows to a body part. A percussor is used 
as a diagnostic aid during physical examinations.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter

[[Page 407]]

subject to the limitations in Sec. 882.9. The device is also exempt from 
the current good manufacturing practice regulations in part 820 of this 
chapter, with the exception of Sec. 820.180, with respect to general 
requirements concerning records, and Sec. 820.198, with respect to 
complaint files.

[44 FR 51730-51778, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 
1989; 59 FR 63011, Dec. 7, 1994; 66 FR 38807, July 25, 2001]