IRE
- Product code
- IRE
- Device name
- Joint, Elbow, External Limb Component, Powered
- Device class
- Class 1
- 21 CFR
- 21 CFR 890.3420
- Medical specialty
- Physical Medicine
- Marketing pathway
- 510(K) Exempt
- Flag
- GMP exempt
- 510(k) clearances (last 3 years)
- 2
Official FDA classification page: IRE
Classification and pathway per current FDA publications. Data from openFDA (CC0).