FDA product code ITO: Twister, Brace Setting
ITO is the FDA product code for twister, brace setting. It is a Class I device, regulated under 21 CFR 890.3410 and reviewed by the Physical Medicine panel. FDA has cleared 1 510(k) submission under ITO. The average 510(k) review took 32 days (median 32).
Classification
| Field | Value |
|---|---|
| Device name | Twister, Brace Setting |
| Device class | Class I |
| Regulation | 21 CFR 890.3410 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Top ITO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ipos Luneburg | 1 | 1980-05-02 |
Most recent ITO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K800716 | Ipos Luneburg | ORTHOTIC LEG GAIT CORRECTOR DEVICE | 1980-05-02 | 32 |
Recalls for ITO devices
openFDA lists no recalls for product code ITO.
Frequently asked questions
What is FDA product code ITO?
ITO is the FDA product code for twister, brace setting. It is a Class I device, regulated under 21 CFR 890.3410 and reviewed by the Physical Medicine panel.
What device class is ITO?
Class I, regulation 21 CFR 890.3410. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ITO?
Across 1 cleared submissions the average was 32 days from receipt to decision (median 32).
Which companies have the most ITO clearances?
Ipos Luneburg (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ITO
- Run a recall and safety report across every ITO manufacturer
- Watch product code ITO 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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