Joint, Elbow, External Limb Component, Powered
A powered external limb component elbow joint is an electrically or pneumatically actuated prosthetic joint providing elbow flexion and extension for upper limb amputees above the elbow level. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IRE, 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
- IRE
- 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 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.