# INK: Stretcher, Wheeled, Powered

- Device class: 2; regulation: 21 CFR 890.3690; FDA's rule: 510(k) exempt
- FDA decisions: 12
- Recalls: 14 (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)
- 1985: 1
- 1991: 1
- 2002: 1
- 2004: 1
- 2005: 1
- 2009: 1
- 2010: 1
- 2011: 2
- 2014: 1
- 2016: 1

## Most-cited predicates
- K022309: Stryker Powered Wheeled Stretcher (2002), cited by 6
- K041924: Hausted Powertran Series Stretcher (2004), cited by 1
- K110671: Winco Stretchair (2011), cited by 1
- K091043: Power Drive Chair, Model: TMM6 (2009), cited by 1

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