FDA product code IRN: Device, Warning, Overload, External Limb, Powered
IRN is the FDA product code for device, warning, overload, external limb, powered. It is a Class II device, regulated under 21 CFR 890.5575 and reviewed by the Physical Medicine panel. FDA has cleared 11 510(k) submissions under IRN, from 10 different applicants. The average 510(k) review took 160 days (median 112).
Classification
| Field | Value |
|---|---|
| Device name | Device, Warning, Overload, External Limb, Powered |
| Device class | Class II |
| Regulation | 21 CFR 890.5575 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IRN clearance
Top IRN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Orthopedic Technology Research, Inc. | 2 | 1999-06-23 |
| Andante Medical Devices , Ltd. | 1 | 2006-02-23 |
| Andante Medical Device, Ltd. | 1 | 2002-12-10 |
| Cleveland Medical Devices, Inc. | 1 | 1996-12-04 |
| Impact Monitors, Inc. | 1 | 1996-04-10 |
5 more applicants have IRN clearances. See the full list in Caduvo.
Most recent IRN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K060150 | Andante Medical Devices , Ltd. | SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM | 2006-02-23 | 34 |
| K023161 | Andante Medical Device, Ltd. | SMARTSTEP SYSTEM | 2002-12-10 | 78 |
| K991313 | Orthopedic Technology Research, Inc. | ACCUTRED SHOE | 1999-06-23 | 68 |
| K962591 | Cleveland Medical Devices, Inc. | FOOT WEIGHT ALARM | 1996-12-04 | 155 |
| K960307 | Orthopedic Technology Research, Inc. | INDEX SHOE | 1996-06-27 | 157 |
Recalls for IRN devices
openFDA lists no recalls for product code IRN.
Frequently asked questions
What is FDA product code IRN?
IRN is the FDA product code for device, warning, overload, external limb, powered. It is a Class II device, regulated under 21 CFR 890.5575 and reviewed by the Physical Medicine panel.
What device class is IRN?
Class II, regulation 21 CFR 890.5575. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IRN?
Across 11 cleared submissions the average was 160 days from receipt to decision (median 112).
Which companies have the most IRN clearances?
Orthopedic Technology Research, Inc. (2); Andante Medical Devices , Ltd. (1); Andante Medical Device, Ltd. (1); Cleveland Medical Devices, Inc. (1); Impact Monitors, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IRN
- Run a recall and safety report across every IRN manufacturer
- Watch product code IRN 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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