Joint, Shoulder, External Limb Component
A shoulder joint external limb component is a prosthetic joint unit that provides articulation at the shoulder level for upper limb amputees, replacing the function of the natural shoulder joint in an external prosthesis. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IQQ, 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
- IQQ
- 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 60 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 60 registration numbers. Click on an entry to view related FDA registrations.