# FMQ: Restraint, Protective

- Device class: 1; regulation: 21 CFR 880.6760; FDA's rule: 510(k) exempt
- FDA decisions: 134
- Recalls: 29 (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
- 1993: 1
- 1996: 90
- 1997: 18
- 1998: 1
- 1999: 2
- 2001: 3
- 2008: 1
- 2009: 1
- 2011: 1

## Most-cited predicates
- K963413: Multiple Limb Holders (1996), cited by 1
- K812473: Head Protector (1981), cited by 1
- K850470: Bed Products (1985), cited by 1
- K013239: Comfortcare Compression Support with Magnets Comfortcare Magnetic Insoles (2001), cited by 1
- K963041: Heelbo Life Jacket with Crotch Support (1996), cited by 1
- K771629: Hand Restraint (1977), cited by 1
- K963099: Heelbo Pullover Poncho and Pullover Poncho with Pocket (1996), cited by 1
- K760618: Patient Restraint (1976), cited by 1
- K963439: Pediatric Limb Holders (1996), cited by 1
- K780232: Restraint, Protective (1978), cited by 1

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