# ITI: Wheelchair, Powered

- Device class: 2; regulation: 21 CFR 890.3860; FDA's rule: 510(k) required
- FDA decisions: 596
- 510(k) review time 2021–2025: median 117 days (middle half 63–204)
- Recalls: 52 (2 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: 4
- 2018: 4
- 2019: 3
- 2020: 6
- 2021: 13
- 2022: 16
- 2023: 8
- 2024: 38
- 2025: 29
- 2026: 36

## Most-cited predicates
- K113463: Power Wheelchair (2012), cited by 13
- K220747: Power Wheelchair (N5515B) (2022), cited by 12
- K960951: Permobil Chairman L/CS 8 (1997), cited by 8
- K945936: JAZZY (1996), cited by 8
- K170787: Powered Wheelchair DYW30A (D09) (2017), cited by 5
- K230964: Power Wheelchair (N5909) (2023), cited by 5
- K062888: Middle Wheel Drive Power Chair, CWD01 (2006), cited by 5
- K231508: Power Wheelchair, W5521 (2023), cited by 5
- K163204: A08 Power wheelchair (2017), cited by 5
- K240913: Electric Wheelchair (HBLD3-B); Electric Wheelchair (HBLD3-E) (2024), cited by 4

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