# IOR: Wheelchair, Mechanical

- Device class: 1; regulation: 21 CFR 890.3850; FDA's rule: 510(k) required
- FDA decisions: 468
- 510(k) review time 2021–2025: median 95 days (middle half 59–273)
- Recalls: 34 (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)
- 2017: 7
- 2018: 3
- 2019: 6
- 2020: 2
- 2021: 2
- 2022: 4
- 2023: 9
- 2024: 4
- 2025: 7
- 2026: 17

## Most-cited predicates
- K935398: Tracer Series Manual Wheelchairs (1994), cited by 12
- K181795: AST Model MA012 and MS019 Rehab Wheelchair (2018), cited by 6
- K201461: Manual Wheelchair, Model A011 (2021), cited by 6
- K890050: Zippie & Quickie 2HP Wheelchair (1989), cited by 6
- K012370: Solara JR. Manual Wheelchair (2001), cited by 4
- K850536: Quickie Wheelchairs (1985), cited by 4
- K984447: Model Action at II Manual Wheelchair (1999), cited by 4
- K063736: Fuze Mechanical Wheelchair, Models T20 and T50 (2007), cited by 4
- K952641: Quickie TSR (1995), cited by 4
- K930411: Universal Wheelchair (1993), cited by 4

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