FMW

14 FDA 510(k) clearances · Product code

FDA profile

Official device name

Cover, Mattress (Medical Purposes)

Device class

Class I (low risk)

Regulation

21 CFR 880.6190

Medical specialty

General Hospital

Flags

GMP exempt

Adverse events (MAUDE)

2003: 3 · 2006: 2 · 2011: 19 · 2012: 13 · 2013: 32 · 2014: 22
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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