KYS
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Insoles, Medical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6280
- Medical specialty
- General Hospital
- Adverse events (MAUDE)
- 1998: 3
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 |
|---|---|---|
| FUNGUS FIGHTER INSOLES (K780719) | Combe, Inc. | 1978-10-10 |
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Every clearance here is in the API, with alerts when new ones post.