ISW
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Assembly, Knee/Shank/Ankle/Foot, External
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3500
- Medical specialty
- Physical Medicine
- Adverse events (MAUDE)
- 2009: 3 · 2012: 9 · 2013: 10 · 2014: 13 · 2015: 9 · 2016: 10
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 |
|---|---|---|
| C-LEG (3C100) (K991590) | Otto Bock Orthopedic Industry, Inc. | 1999-07-08 |
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Every clearance here is in the API, with alerts when new ones post.