Joint, Elbow, External Limb Component, Mechanical
A mechanical external limb component elbow joint is a body-powered prosthetic joint component that provides elbow articulation for upper limb amputees above the elbow, using cable and harness mechanisms for flexion and locking. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IRD, 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
- IRD
- Device Class
- FDA class 1
- Regulation Number
- 890.3420
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 31 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 31 registration numbers. Click on an entry to view related FDA registrations.