IOE

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Bars, Parallel, Exercise

Device class

Class I (low risk)

Regulation

21 CFR 890.5370

Medical specialty

Physical Medicine

Flags

GMP exempt

Adverse events (MAUDE)

1992: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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