ISW · Assembly, Knee/Shank/Ankle/Foot, External
Physical Medicine · 21 CFR 890.3500 · Class 2
Overview
| Product Code | ISW |
|---|---|
| Device Name | Assembly, 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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K991590 | C-LEG (3C100) | Otto Bock Orthopedic Industry, Inc. | Jul 8, 1999 | SESE |
Top Applicants
- Otto Bock Orthopedic Industry, Inc. — 1 clearance
