[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR888.1500]

[Page 456]
 
                        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. 888.1500  Goniometer.

    (a) Identification. A goniometer is an AC-powered or battery powered 
device intended to evaluate joint function by measuring and recording 
ranges of motion, acceleration, or forces exerted by a joint.
    (b) Classification. (1) Class I (general controls) for a goniometer 
that does not use electrode lead wires and patient cables. This device 
is exempt from the premarket notification procedures of subpart E of 
part 807 of this chapter subject to Sec. 888.9.
    (2) Class II (special controls) for a goniometer that uses electrode 
lead wires and patient cables. The special controls consist of:
    (i) The performance standard under part 898 of this chapter, and
    (ii) The guidance entitled ``Guidance on the Performance Standard 
for Electrode Lead Wires and Patient Cables.'' This device is exempt 
from the premarket notification procedures of subpart E of part 807 of 
this chapter subject to Sec. 888.9.

[65 FR 19319, Apr. 11, 2000]