FDA product code IOG: Treadmill, Mechanical
IOG is the FDA product code for treadmill, mechanical. It is a Class I device, regulated under 21 CFR 890.5370 and reviewed by the Physical Medicine panel. FDA has cleared 3 510(k) submissions under IOG, from 3 different applicants. The average 510(k) review took 102 days (median 56).
Classification
| Field | Value |
|---|---|
| Device name | Treadmill, Mechanical |
| 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 IOG clearance
Top IOG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Stryker Medical | 1 | 1992-09-21 |
| Medichanics, Inc. | 1 | 1980-06-17 |
| Associated Mills, Inc. | 1 | 1980-04-02 |
Most recent IOG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K920526 | Stryker Medical | STRYKER DYNAMIC MATTRESS SYSTEM (DMS) MODEL #2500 | 1992-09-21 | 230 |
| K801250 | Medichanics, Inc. | HYDRA TRED DC | 1980-06-17 | 20 |
| K800251 | Associated Mills, Inc. | MT-10, ET-20 | 1980-04-02 | 56 |
Recalls for IOG devices
openFDA lists no recalls for product code IOG.
Frequently asked questions
What is FDA product code IOG?
IOG is the FDA product code for treadmill, mechanical. It is a Class I device, regulated under 21 CFR 890.5370 and reviewed by the Physical Medicine panel.
What device class is IOG?
Class I, regulation 21 CFR 890.5370. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IOG?
Across 3 cleared submissions the average was 102 days from receipt to decision (median 56).
Which companies have the most IOG clearances?
Stryker Medical (1); Medichanics, Inc. (1); Associated Mills, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IOG
- Run a recall and safety report across every IOG manufacturer
- Watch product code IOG 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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