21 C.F.R. § 890.3490 Truncal orthosis.
Title 21 - Food and Drugs
(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 §890.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of §820.180, regarding general requirements concerning records and §820.198, regarding complaint files. [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001]
Title 21: Food and Drugs
PART 890—PHYSICAL MEDICINE DEVICES
Subpart D—Physical Medicine Prosthetic Devices
§ 890.3490 Truncal orthosis.
