Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical
Mechanical Shoulder, Elbow, Forearm, Wrist, and Hand Assembly is a passive upper-limb prosthetic component system that mechanically replicates the function of one or more upper extremity joints and segments, restoring mobility and functional capacity to patients with upper limb loss or impairment. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KFT, regulated under 21 CFR 890.3420, within the Physical Medicine medical specialty.
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Basic Information
- Product Code
- KFT
- 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 16 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.