# ILH: Splint, Hand, And Components

- Device class: 1; regulation: 21 CFR 890.3475; FDA's rule: 510(k) exempt
- FDA decisions: 36
- Recalls: 1 (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)
- 1976: 5
- 1977: 1
- 1978: 3
- 1979: 3
- 1980: 3
- 1981: 5
- 1982: 12
- 1983: 4

## Most-cited predicates

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