IPG
6 FDA 510(k) clearances · Product code
24 daysmedian time to decision
44 days90th percentile
6clearances measured
FDA profile
- Official device name
- Shoe, Cast
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3025
- Medical specialty
- Physical Medicine
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1992: 1 · 2001: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| NESS CHILDREN SYSTEM (K024279) | Ness-Neuromuscular Electrical Stimulation Systems | 2003-02-05 |
| TOGUARD (K790652) | Togard, Inc. | 1979-04-04 |
| CAST SHOE (K781363) | Cutler Biomedical | 1978-08-14 |
| EQUALIZER (K780617) | Ballert Orthopedic Corp. | 1978-04-18 |
| ROCKER-SOLE CAST SANDAL (K760575) | Richard'S Medical Equip., Inc. | 1976-10-06 |
| BALANCED CAST SOLE (K760578) | Parke-Davis Co. | 1976-09-27 |
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Every clearance here is in the API, with alerts when new ones post.