IQE

4 FDA 510(k) clearances · Product code

FDA profile

Official device name

Orthosis, Lumbar

Device class

Class I (low risk)

Regulation

21 CFR 890.3490

Medical specialty

Physical Medicine

Flags

GMP exempt

Adverse events (MAUDE)

2001: 3 · 2004: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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