ANKLE/FOOT EXTERNAL
Device Facts
| Record ID | K820505 |
|---|---|
| Device Name | ANKLE/FOOT EXTERNAL |
| Applicant | Mauch Laboratories, Inc. |
| Product Code | ISH · Physical Medicine |
| Decision Date | Mar 8, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3420 |
| Device Class | Class 1 |
Regulatory Classification
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.
