FDA product code IOE: Bars, Parallel, Exercise
IOE is the FDA product code for bars, parallel, exercise. It is a Class I device, regulated under 21 CFR 890.5370 and reviewed by the Physical Medicine panel. FDA has cleared 2 510(k) submissions under IOE, from 2 different applicants. The average 510(k) review took 15 days (median 15).
Classification
| Field | Value |
|---|---|
| Device name | Bars, Parallel, Exercise |
| Device class | Class I |
| Regulation | 21 CFR 890.5370 |
| 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 IOE clearance
Top IOE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kaye Products, Inc. | 1 | 1983-03-09 |
| Will Ross Co. | 1 | 1977-04-08 |
Most recent IOE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K830466 | Kaye Products, Inc. | BARS, PARALLEL, EXERCISE | 1983-03-09 | 22 |
| K770611 | Will Ross Co. | PARALLEL BARS | 1977-04-08 | 8 |
Recalls for IOE devices
openFDA lists no recalls for product code IOE.
Frequently asked questions
What is FDA product code IOE?
IOE is the FDA product code for bars, parallel, exercise. It is a Class I device, regulated under 21 CFR 890.5370 and reviewed by the Physical Medicine panel.
What device class is IOE?
Class I, regulation 21 CFR 890.5370. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IOE?
Across 2 cleared submissions the average was 15 days from receipt to decision (median 15).
Which companies have the most IOE clearances?
Kaye Products, Inc. (1); Will Ross Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IOE
- Run a recall and safety report across every IOE manufacturer
- Watch product code IOE 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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