Assembly, Thigh/Knee/Shank/Ankle/Foot, External
External Thigh, Knee, Shank, Ankle, and Foot Assembly is an externally worn lower-limb prosthetic component system that provides structural and functional support for one or more lower extremity segments, restoring ambulatory capability for patients with lower limb loss or impairment. It is classified as FDA Class 2, indicating moderate risk; devices in this category are subject to general controls and special controls, and typically require 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is KFX, regulated under 21 CFR 890.3500, within the Physical Medicine medical specialty.
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Basic Information
- Product Code
- KFX
- Device Class
- FDA class 2
- Regulation Number
- 890.3500
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K932184 | STERILE LEMAITRE GLOW 'N TELL TAPE | Jul 22, 1993 | Substantially Equivalent | Vascutech, Inc. |
| K833868 | IPOS G.L.P. SYSTEM | Nov 28, 1983 | Substantially Equivalent | Ipos Luneburg |
| K830285 | REGNELL HYDRAULIC FEMORAL PROTHESIS | Mar 09, 1983 | Substantially Equivalent | Besco Financial Service |
| K822240 | ETHYLENE OXIDE STERILIZ. PARAMETRIC REL. | Dec 30, 1982 | Substantially Equivalent | American Mcgaw |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.