FDA product code ITN: Splint, Denis Brown
ITN is the FDA product code for splint, denis brown. It is a Class I device, regulated under 21 CFR 890.3675 and reviewed by the Physical Medicine panel. FDA has cleared 3 510(k) submissions under ITN, from 3 different applicants. The average 510(k) review took 50 days (median 54).
Classification
| Field | Value |
|---|---|
| Device name | Splint, Denis Brown |
| Device class | Class I |
| Regulation | 21 CFR 890.3675 |
| 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 ITN clearance
Top ITN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ep Medsystems | 1 | 2007-05-01 |
| Yeou Eir Shuen Machinery Co., Ltd. | 1 | 2003-11-12 |
| The Langer Group | 1 | 1982-06-23 |
Most recent ITN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K071028 | Ep Medsystems | VIEWMATE SYSTEM | 2007-05-01 | 20 |
| K032669 | Yeou Eir Shuen Machinery Co., Ltd. | Y.E.S. POWERED WHEELCHAIR, MODEL T200 | 2003-11-12 | 76 |
| K821256 | The Langer Group | COUNTER-ROTATION SYSTEM | 1982-06-23 | 54 |
Recalls for ITN devices
openFDA lists no recalls for product code ITN.
Frequently asked questions
What is FDA product code ITN?
ITN is the FDA product code for splint, denis brown. It is a Class I device, regulated under 21 CFR 890.3675 and reviewed by the Physical Medicine panel.
What device class is ITN?
Class I, regulation 21 CFR 890.3675. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ITN?
Across 3 cleared submissions the average was 50 days from receipt to decision (median 54).
Which companies have the most ITN clearances?
Ep Medsystems (1); Yeou Eir Shuen Machinery Co., Ltd. (1); The Langer Group (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ITN
- Run a recall and safety report across every ITN manufacturer
- Watch product code ITN 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.
All Physical Medicine product codes · FDA product code lookup · 510(k) database search · 510(k) review times