FDA product code ISH: Component, External, Limb, Ankle/Foot
ISH is the FDA product code for component, external, limb, ankle/foot. It is a Class I device, regulated under 21 CFR 890.3420 and reviewed by the Physical Medicine panel. FDA has cleared 4 510(k) submissions under ISH, from 4 different applicants. The average 510(k) review took 28 days (median 16). FDA has posted 13 recalls for ISH devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Component, External, Limb, Ankle/Foot |
| Device class | Class I |
| Regulation | 21 CFR 890.3420 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every ISH clearance
Top ISH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Noble Fiber Technologies, Inc. | 1 | 2005-07-21 |
| Orthopedic Systems, Inc. | 1 | 1982-11-29 |
| Mauch Laboratories, Inc. | 1 | 1982-03-08 |
| Kiswood Manufacturing, Inc. | 1 | 1979-08-03 |
Most recent ISH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K051256 | Noble Fiber Technologies, Inc. | SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC | 2005-07-21 | 66 |
| K823396 | Orthopedic Systems, Inc. | FREE FLEX HEEL HEIGHT ADJUSTOR | 1982-11-29 | 17 |
| K820505 | Mauch Laboratories, Inc. | ANKLE/FOOT EXTERNAL | 1982-03-08 | 11 |
| K791331 | Kiswood Manufacturing, Inc. | THE TUCKER-SACH FOOT AND TUCKER-SYME FT | 1979-08-03 | 16 |
Recalls for ISH devices
13 product recalls in 13 recall events; 2 initiated in the last five years and 1 still open. Most recent: 2023-05-12.
| Year | Recalls |
|---|---|
| 2022 | 1 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code ISH?
ISH is the FDA product code for component, external, limb, ankle/foot. It is a Class I device, regulated under 21 CFR 890.3420 and reviewed by the Physical Medicine panel.
What device class is ISH?
Class I, regulation 21 CFR 890.3420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ISH?
Across 4 cleared submissions the average was 28 days from receipt to decision (median 16).
Which companies have the most ISH clearances?
Noble Fiber Technologies, Inc. (1); Orthopedic Systems, Inc. (1); Mauch Laboratories, Inc. (1); Kiswood Manufacturing, Inc. (1).
Have ISH devices been recalled?
Yes: 13 product recalls across 13 recall events; the most recent began 2023-05-12.
Next steps
- Run an FDA pathway report with predicate devices for product code ISH
- Run a recall and safety report across every ISH manufacturer
- Watch product code ISH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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