# FMW: Cover, Mattress (Medical Purposes)

- Device class: 1; regulation: 21 CFR 880.6190; FDA's rule: 510(k) exempt
- FDA decisions: 14
- Recalls: 2 (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)
- 1978: 1
- 1984: 1
- 1990: 2
- 1992: 2
- 1993: 3
- 1994: 1
- 1999: 1
- 2001: 1
- 2007: 1
- 2016: 1

## Most-cited predicates
- K903382: Allergy Control Covers (1990), cited by 2
- K061242: Dermatherapy, Model 22216 (2007), cited by 1
- K780033: Mattresses, Conductive & Covers (1978), cited by 1

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