# IQI: Orthosis, Limb Brace

- Device class: 1; regulation: 21 CFR 890.3475; FDA's rule: 510(k) exempt
- FDA decisions: 52
- Recalls: 7 (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)
- 1980: 9
- 1981: 8
- 1982: 10
- 1983: 3
- 1987: 1
- 1991: 1
- 1993: 1
- 2003: 1
- 2006: 1
- 2015: 1

## Most-cited predicates
- K821582: Warm'n Form Sports Supports (1982), cited by 1

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