FDA product code IOD: Components, Exercise
IOD is the FDA product code for components, exercise. It is a Class I device, regulated under 21 CFR 890.5350 and reviewed by the Physical Medicine panel. FDA has cleared 11 510(k) submissions under IOD, from 5 different applicants. The average 510(k) review took 23 days (median 18).
Classification
| Field | Value |
|---|---|
| Device name | Components, Exercise |
| Device class | Class I |
| Regulation | 21 CFR 890.5350 |
| 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 IOD clearance
Top IOD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fred Sammons, Inc. | 7 | 1983-06-24 |
| Danek Medical, Inc. | 1 | 1983-01-14 |
| Kaye Products, Inc. | 1 | 1981-08-31 |
| Maddak, Inc. | 1 | 1979-04-03 |
| Stat Medical Corp. | 1 | 1977-06-27 |
Most recent IOD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K831544 | Fred Sammons, Inc. | DELUXE TRACTION EXERCISE GLOVE BK5035 | 1983-06-24 | 43 |
| K823648 | Fred Sammons, Inc. | SURGICAL TUBING | 1983-01-21 | 46 |
| K823822 | Danek Medical, Inc. | ANKLE WEIGHTS | 1983-01-14 | 28 |
| K823600 | Fred Sammons, Inc. | SOLID WOOD CONE | 1982-12-22 | 16 |
| K813632 | Fred Sammons, Inc. | COLOR CODED WEIGHT CUFFS | 1982-01-19 | 21 |
Recalls for IOD devices
openFDA lists no recalls for product code IOD.
Frequently asked questions
What is FDA product code IOD?
IOD is the FDA product code for components, exercise. It is a Class I device, regulated under 21 CFR 890.5350 and reviewed by the Physical Medicine panel.
What device class is IOD?
Class I, regulation 21 CFR 890.5350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IOD?
Across 11 cleared submissions the average was 23 days from receipt to decision (median 18).
Which companies have the most IOD clearances?
Fred Sammons, Inc. (7); Danek Medical, Inc. (1); Kaye Products, Inc. (1); Maddak, Inc. (1); Stat Medical Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IOD
- Run a recall and safety report across every IOD manufacturer
- Watch product code IOD 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