Component, External, Limb, Ankle/Foot
An ankle/foot external limb component is a prosthetic unit providing ankle and foot function for lower limb amputees, designed to replicate the biomechanical roles of the natural ankle and foot during standing and ambulation. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is ISH, regulated under 21 CFR 890.3420, within the Physical Medicine medical specialty. This device is GMP exempt.
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Basic Information
- Product Code
- ISH
- Device Class
- FDA class 1
- Regulation Number
- 890.3420
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K051256 | SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC | Jul 21, 2005 | Substantially Equivalent | Noble Fiber Technologies, Inc. |
| K823396 | FREE FLEX HEEL HEIGHT ADJUSTOR | Nov 29, 1982 | Substantially Equivalent | Orthopedic Systems, Inc. |
| K820505 | ANKLE/FOOT EXTERNAL | Mar 08, 1982 | Substantially Equivalent | Mauch Laboratories, Inc. |
| K791331 | THE TUCKER-SACH FOOT AND TUCKER-SYME FT | Aug 03, 1979 | Substantially Equivalent | Kiswood Manufacturing, Inc. |
FEI Numbers
This FDA classification entry is associated with 85 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 85 registration numbers. Click on an entry to view related FDA registrations.