21 CFR 890.3500 — Assembly, Knee/Shank/Ankle/Foot, External
Physical Medicine (PM) · Part 890 Subpart D—Physical Medicine Prosthetic Devices · § 890.3500
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| ISW | Assembly, Knee/Shank/Ankle/Foot, External | 2 | 1 | |
| KFX | Assembly, Thigh/Knee/Shank/Ankle/Foot, External | 2 | 4 |
Special Controls
ISW — Assembly, Knee/Shank/Ankle/Foot, External
*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.
eCFR
KFX — Assembly, Thigh/Knee/Shank/Ankle/Foot, External
*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.
eCFR
