Panels › Physical Medicine › Product code ISH · Class 1
Component, External, Limb, Ankle/Foot
Regulation 890.3420
0510(k)s in 12 months (4 all time)
0recalls in 12 months (13 all time)
0recalls that name a 510(k)
Top companies in ISH
| Company | 510(k)s | Recalls |
|---|---|---|
| Ossur | 0 | 2 |
| Ossur Americas | 0 | 2 |
| Ossur H / F | 0 | 2 |
| Ossur North America Inc | 0 | 2 |
| Applied Composite Technology | 0 | 1 |
| Bock,Otto,Orthopedic Ind,Inc | 0 | 1 |
| College Park Industries, Inc. | 0 | 1 |
| Kiswood Manufacturing, Inc. | 1 | 0 |
| Mauch Laboratories, Inc. | 1 | 0 |
| Noble Fiber Technologies, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 21, 2005 | K051256 | SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC Noble Fiber Technologies, Inc. | ISH |
| Nov 29, 1982 | K823396 | FREE FLEX HEEL HEIGHT ADJUSTOR Orthopedic Systems, Inc. | ISH |
| Mar 8, 1982 | K820505 | ANKLE/FOOT EXTERNAL Mauch Laboratories, Inc. | ISH |
| Aug 3, 1979 | K791331 | THE TUCKER-SACH FOOT AND TUCKER-SYME FT Kiswood Manufacturing, Inc. | ISH |
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