Hook, External Limb Component, Mechanical
A mechanical external limb component hook is a body-powered terminal device for upper limb prostheses that uses cable and harness systems to enable prehension, serving as a functional replacement for the hand. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IQX, 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
- IQX
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K780890 | CAPP TERMINAL DEVICE | Jun 13, 1978 | Substantially Equivalent | Hosmer Dorrance Corp. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.