# IKZ: Bed, Patient Rotation, Powered

- Device class: 2; regulation: 21 CFR 890.5225; FDA's rule: 510(k) exempt
- FDA decisions: 17
- Recalls: 8 (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)
- 1987: 1
- 1990: 1
- 1991: 1
- 1992: 1
- 1993: 1
- 1994: 1
- 1995: 2
- 1996: 1
- 1997: 1
- 1998: 2

## Most-cited predicates
- K972111: Rumors Dynamic Air Therapy Unit (1998), cited by 1

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