CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 882—NEUROLOGICAL DEVICES > SUBPART B—Neurological Diagnostic Devices (§882.1020 to §882.1950) > 882.1750—Pinwheel.

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 § 882.9.

Code of Federal Regulations

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