Shoe, Cast
FDA product code IPG · Class I (low risk) · 21 CFR 890.3025 · Physical Medicine
6510(k) clearances
0PMA approvals
0recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K024279 | Ness Children SystemIPG · Traditional | Ness-Neuromuscular Electrical Stimulation Systems | 02/05/2003SE |
| K790652 | ToguardIPG · Traditional | Togard, Inc. | 04/04/1979SE |
| K781363 | Cast ShoeIPG · Traditional | Cutler Biomedical | 08/14/1978SE |
| K780617 | EqualizerIPG · Traditional | Ballert Orthopedic Corp. | 04/18/1978SE |
| K760575 | Rocker-Sole Cast SandalIPG · Traditional | Richard'S Medical Equip., Inc. | 10/06/1976SE |
| K760578 | Balanced Cast SoleIPG · Traditional | Parke-Davis Co. | 09/27/1976SE |