ISH
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Component, External, Limb, Ankle/Foot
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3420
- Medical specialty
- Physical Medicine
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2000: 1 · 2001: 3 · 2002: 2 · 2004: 3 · 2016: 9 · 2023: 21
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 |
|---|---|---|
| SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC (K051256) | Noble Fiber Technologies, Inc. | 2005-07-21 |
| FREE FLEX HEEL HEIGHT ADJUSTOR (K823396) | Orthopedic Systems, Inc. | 1982-11-29 |
| ANKLE/FOOT EXTERNAL (K820505) | Mauch Laboratories, Inc. | 1982-03-08 |
| THE TUCKER-SACH FOOT AND TUCKER-SYME FT (K791331) | Kiswood Manufacturing, Inc. | 1979-08-03 |
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Every clearance here is in the API, with alerts when new ones post.