RESTRAINT, PROTECTIVE
Device Facts
| Record ID | K801628 |
|---|---|
| Device Name | RESTRAINT, PROTECTIVE |
| Applicant | The Owenby Co. |
| Product Code | IQK · Physical Medicine |
| Decision Date | Aug 7, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3490 |
| Device Class | Class 1 |
Regulatory Classification
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.
