SOFTGOOD PRODUCTS AND SPLINTS
Device Facts
| Record ID | K803239 |
|---|---|
| Device Name | SOFTGOOD PRODUCTS AND SPLINTS |
| Applicant | Danek Medical, Inc. |
| Product Code | IPX · Physical Medicine |
| Decision Date | Jan 9, 1981 |
| 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.
