# IMK: Wheelchair, Stair Climbing

- Device class: 2; regulation: 21 CFR 890.3890; FDA's rule: 510(k) required
- FDA decisions: 5
- 510(k) review time 2021–2025: median 82 days (middle half 81–84)
- Recalls: 3 (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)
- 1991: 1
- 1993: 1
- 2003: 1
- 2004: 1
- 2005: 1
- 2018: 1
- 2021: 1
- 2025: 1

## Most-cited predicates
- P020033/S002: Independence Ibot 3000/4000 Mobility System (2005), cited by 1
- K172601: Next Generation iBOT (2018), cited by 1
- K210920: iBOT Personal Mobility Device (iBOT PMD) (2021), cited by 1

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