# IOQ: Bed, Flotation Therapy, Powered

- Device class: 2; regulation: 21 CFR 890.5170; FDA's rule: 510(k) exempt
- FDA decisions: 57
- Recalls: 24 (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)
- 1990: 6
- 1991: 5
- 1992: 5
- 1993: 6
- 1994: 1
- 1995: 4
- 1997: 5
- 1998: 1
- 2013: 1
- 2015: 1

## Most-cited predicates
- K923977: Akrotech 4000 (1993), cited by 2
- K951001: Flexicair Exlipse (1995), cited by 2
- K945729: Dynamicaire (TM) Sleep Surface, Zoneair (TM) Sleep Surface (1995), cited by 1
- K875321: Modified Rotation Air Fluidized Bed/the Therapulse (1988), cited by 1
- K863047: Flexicair (1986), cited by 1
- K931594: Thera-Turn CM-1000 Mattress Overlay System (1993), cited by 1
- K970636: Totalcare., Modular Therapy System (MTS) (1997), cited by 1

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