Hand, External Limb Component, Mechanical
A mechanical external limb component hand is a body-powered prosthetic terminal device designed to replicate the appearance and function of a natural hand for upper limb amputees, using cable-driven mechanisms for grasp and release. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IRA, regulated under 21 CFR 890.3420, within the Physical Medicine medical specialty. This device is GMP exempt.
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Basic Information
- Product Code
- IRA
- Device Class
- FDA class 1
- Regulation Number
- 890.3420
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 35 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 35 registration numbers. Click on an entry to view related FDA registrations.