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IRA

Hand, External Limb Component, Mechanical

Product code
IRA
Device name
Hand, External Limb Component, Mechanical
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 (all years, FDA)
2 (all years; only the last 3 years are listed here)
Official FDA classification page: IRA
Classification and pathway per current FDA publications. Data from openFDA (CC0).