21 CFR 890.3420 — Joint, Shoulder, External Limb Component
Physical Medicine (PM) · Part 890 Subpart D—Physical Medicine Prosthetic Devices · § 890.3420
Identification
An external limb prosthetic component is a device intended for medical purposes that, when put together with other appropriate components, constitutes a total prosthesis. Examples of external limb prosthetic components include the following: Ankle, foot, hip, knee, and socket components; mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components; and cable and prosthesis suction valves.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IQQ | Joint, Shoulder, External Limb Component | 1 | 0 | |
| IQW | Hook, External Limb Component, Powered | 1 | 0 | |
| IQX | Hook, External Limb Component, Mechanical | 1 | 1 | |
| IQZ | Hand, External Limb Component, Powered | 1 | 0 | |
| IRA | Hand, External Limb Component, Mechanical | 1 | 2 | |
| IRD | Joint, Elbow, External Limb Component, Mechanical | 1 | 0 | |
| IRE | Joint, Elbow, External Limb Component, Powered | 1 | 2 | |
| ISH | Component, External, Limb, Ankle/Foot | 1 | 4 | |
| ISL | Joint, Hip, External Limb Component | 1 | 0 | |
| ISN | Cable | 1 | 0 | |
| ISP | Valve, Prosthesis | 1 | 1 | |
| ISS | Prosthesis, Thigh Socket, External Component | 1 | 1 | |
| ISY | Joint, Knee, External Limb Component | 1 | 1 | |
| ISZ | Unit, Wrist, External Limb Component, Mechanical | 1 | 0 | |
| KFT | Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical | 1 | 0 | |
| KFW | Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Powered | 1 | 0 | |
| KGH | Unit, Wrist, External Limb Component, Powered | 1 | 0 |
