ITW

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Joint, Ankle, External Brace

Device class

Class I (low risk)

Regulation

21 CFR 890.3475

Medical specialty

Physical Medicine

Flags

GMP exempt

Adverse events (MAUDE)

1994: 1 · 1999: 4 · 2001: 1 · 2002: 1 · 2016: 13 · 2018: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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