# ISW: Assembly, Knee/Shank/Ankle/Foot, External

- Device class: 2; regulation: 21 CFR 890.3500; FDA's rule: 510(k) exempt
- FDA decisions: 1
- Recalls: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1999: 1

## Most-cited predicates
- K991590: C-LEG (3C100) (1999), cited by 1

Source page: https://510kreport.com/product-code/ISW
Data by year (CSV): https://510kreport.com/product-code/ISW.csv