FDA product code IOY: Support, Arm
IOY is the FDA product code for support, arm. It is a Class I device, regulated under 21 CFR 890.3475 and reviewed by the Physical Medicine panel. FDA has cleared 1 510(k) submission under IOY. The average 510(k) review took 21 days (median 21).
Classification
| Field | Value |
|---|---|
| Device name | Support, Arm |
| Device class | Class I |
| Regulation | 21 CFR 890.3475 |
| 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 IOY clearance
Top IOY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Richard F. Kronner, M.D. | 1 | 1977-02-02 |
Most recent IOY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K770065 | Richard F. Kronner, M.D. | ADJUSTABLE ARM SUPPORT | 1977-02-02 | 21 |
Recalls for IOY devices
openFDA lists no recalls for product code IOY.
Frequently asked questions
What is FDA product code IOY?
IOY is the FDA product code for support, arm. It is a Class I device, regulated under 21 CFR 890.3475 and reviewed by the Physical Medicine panel.
What device class is IOY?
Class I, regulation 21 CFR 890.3475. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IOY?
Across 1 cleared submissions the average was 21 days from receipt to decision (median 21).
Which companies have the most IOY clearances?
Richard F. Kronner, M.D. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IOY
- Run a recall and safety report across every IOY manufacturer
- Watch product code IOY 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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