ISH · Component, External, Limb, Ankle/Foot
Physical Medicine · 21 CFR 890.3420 · Class 1
Overview
| Product Code | ISH |
|---|---|
| Device Name | Component, External, Limb, Ankle/Foot |
| Regulation | 21 CFR 890.3420 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| GMP Exempt | Yes |
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.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K051256 | SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC | Noble Fiber Technologies, Inc. | Jul 21, 2005 | SESE |
| K823396 | FREE FLEX HEEL HEIGHT ADJUSTOR | Orthopedic Systems, Inc. | Nov 29, 1982 | SESE |
| K820505 | ANKLE/FOOT EXTERNAL | Mauch Laboratories, Inc. | Mar 8, 1982 | SESE |
| K791331 | THE TUCKER-SACH FOOT AND TUCKER-SYME FT | Kiswood Manufacturing, Inc. | Aug 3, 1979 | SESE |
Top Applicants
- Kiswood Manufacturing, Inc. — 1 clearance
- Mauch Laboratories, Inc. — 1 clearance
- Noble Fiber Technologies, Inc. — 1 clearance
- Orthopedic Systems, Inc. — 1 clearance
