KFX · Assembly, Thigh/Knee/Shank/Ankle/Foot, External
Physical Medicine · 21 CFR 890.3500 · Class 2
Overview
| Product Code | KFX |
|---|---|
| Device Name | Assembly, Thigh/Knee/Shank/Ankle/Foot, External |
| Regulation | 21 CFR 890.3500 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
Identification
An external assembled lower limb prosthesis is a device that is intended for medical purposes and is a preassembled external artificial limb for the lower extremity. Examples of external assembled lower limb prostheses are the following: Knee/shank/ankle/foot assembly and thigh/knee/shank/ankle/foot assembly.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K932184 | STERILE LEMAITRE GLOW 'N TELL TAPE | Vascutech, Inc. | Jul 22, 1993 | SESE |
| K833868 | IPOS G.L.P. SYSTEM | Ipos Luneburg | Nov 28, 1983 | SESE |
| K830285 | REGNELL HYDRAULIC FEMORAL PROTHESIS | Besco Financial Service | Mar 9, 1983 | SESE |
| K822240 | ETHYLENE OXIDE STERILIZ. PARAMETRIC REL. | American Mcgaw | Dec 30, 1982 | SESE |
Top Applicants
- American Mcgaw — 1 clearance
- Besco Financial Service — 1 clearance
- Ipos Luneburg — 1 clearance
- Vascutech, Inc. — 1 clearance
