[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: 21CFR890.3490]

[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. 890.3490  Truncal orthosis.

    (a) Identification. A truncal orthosis is a device intended for 
medical purposes to support or to immobilize fractures, strains, or 
sprains of the neck or trunk of the body. Examples of truncal orthoses 
are the following: Abdominal, cervical, cervical-thoracic, lumbar, 
lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and 
clavicle splints.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification precedures 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.