[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR890.3490]

[Page 522]
 
                        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 procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9. The device is 
also exempt from the current good manufacturing practice regulations in 
part 820 of this chapter, with the exception of Sec. 820.180, regarding 
general requirements concerning records and Sec. 820.198, regarding 
complaint files.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001]