[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: 21CFR890.3475]

[Page 482]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 890--PHYSICAL MEDICINE DEVICES--Table of Contents
 
             Subpart D--Physical Medicine Prosthetic Devices
 
Sec. 890.3475  Limb orthosis.

    (a) Identification. A limb orthosis (brace) is a device intended for 
medical purposes that is worn on the upper or lower extremities to 
support, to correct, or to prevent deformities or to align body 
structures for functional improvement. Examples of limb orthoses include 
the following: A whole limb and joint brace, a hand splint, an elastic 
stocking, a knee cage, and a corrective shoe.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807. The 
device also is exempt from the current good manufacturing practice 
regulations in part 820, with the exception of Sec. 820.180, with 
respect to general requirements concerning records, and Sec. 820.198, 
with respect to complaint files.