Orthosis, Thoracic
FDA product code IPT · Class I (low risk) · 21 CFR 890.3490 · Physical Medicine
5510(k) clearances
0PMA approvals
0recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K963091 | Vollman Prone PositionerIPT · Traditional | Hill-Rom, Inc. | 01/09/1997SE |
| K821645 | Back SkpportsIPT · Traditional | Fred Sammons, Inc. | 06/11/1982SE |
| K812401 | Cruciform Anterior Spinal Hyperexten. OIPT · Traditional | Surgical Appliance Industries, Inc. | 09/14/1981SE |
| K811750 | Multitubular Thoracic Air SplintsIPT · Traditional | Roger Cestac & Assoc. | 07/20/1981SE |
| K761128 | Lateral Trunk SupportsIPT · Traditional | Fred Sammons, Inc. | 12/02/1976SE |