ISH — Component, External, Limb, Ankle/Foot Class I
FDA product code ISH covers "Component, External, Limb, Ankle/Foot", a Class I medical device regulated under 21 CFR 890.3420. Submissions are reviewed by the Physical Medicine panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ISH
- Device Class
- Class I
- Regulation Number
- 890.3420
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K051256 | noble fiber technologies | SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC | July 21, 2005 |
| K823396 | orthopedic systems | FREE FLEX HEEL HEIGHT ADJUSTOR | November 29, 1982 |
| K820505 | mauch laboratories | ANKLE/FOOT EXTERNAL | March 8, 1982 |
| K791331 | kiswood manufacturing | THE TUCKER-SACH FOOT AND TUCKER-SYME FT | August 3, 1979 |