[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: 21CFR888.1520]

[Page 475]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 888--ORTHOPEDIC DEVICES--Table of Contents
 
                      Subpart B--Diagnostic Devices
 
Sec. 888.1520  Nonpowered goniometer.

    (a) Identification. A nonpowered goniometer is a mechanical device 
intended for medical purposes to measure the range of motion of joints.
    (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 the limitations in Sec. 888.9.

[52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001]

Subpart C [Reserved]