Unit, Wrist, External Limb Component, Mechanical
A mechanical wrist unit external limb component is a prosthetic wrist joint component for upper limb amputees that provides rotational and positional adjustment of the terminal device using mechanical means, allowing more natural tool orientation. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is ISZ, 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
- ISZ
- 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 34 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 34 registration numbers. Click on an entry to view related FDA registrations.