[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: 21CFR882.1750]

[Page 416]
 
                        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. 882.1750  Pinwheel.

    (a) Identification. A pinwheel is a device with sharp points on a 
rotating wheel used for testing pain sensation.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 882.9.

[44 FR 51730-51778, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 
1989; 65 FR 2319, Jan. 14, 2000]