# IQC: Wheelchair, Special Grade

- Device class: 2; regulation: 21 CFR 890.3880; FDA's rule: 510(k) required
- FDA decisions: 24
- 510(k) review time 2021–2025: median 32 days (middle half 32–32)
- Recalls: 0 (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)
- 1977: 2
- 1980: 1
- 1983: 2
- 1984: 13
- 1986: 1
- 1989: 1
- 2005: 1
- 2009: 1
- 2012: 1
- 2025: 1

## Most-cited predicates
- K051709: Hippocampe Wheelchair (2005), cited by 2
- K840631: Arnas Wheelchair (1984), cited by 1

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