FDA product code IOA: Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat
IOA is the FDA product code for diathermy, microwave, for use in applying therapeutic deep heat. It is a Class II device, regulated under 21 CFR 890.5275 and reviewed by the Physical Medicine panel. FDA has cleared 4 510(k) submissions under IOA, from 4 different applicants. The average 510(k) review took 308 days (median 216).
Classification
| Field | Value |
|---|---|
| Device name | Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat |
| Device class | Class II |
| Regulation | 21 CFR 890.5275 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every IOA clearance
Top IOA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cheung Laboratories, Inc. | 1 | 1996-04-22 |
| Nemectron Medical, Inc. | 1 | 1990-07-27 |
| Elmed, Inc. | 1 | 1986-07-16 |
| Medical Microwave Research Corp. | 1 | 1986-03-27 |
Most recent IOA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K941567 | Cheung Laboratories, Inc. | DIATHERMY DEVICE-MICROFOCUS | 1996-04-22 | 752 |
| K895000 | Nemectron Medical, Inc. | NEMECTRON MICROWAVE | 1990-07-27 | 353 |
| K862029 | Elmed, Inc. | SIEMENS RADIOTHERM 706, MICROWAVE THERAPY UNIT | 1986-07-16 | 49 |
| K860082 | Medical Microwave Research Corp. | THERMOTRON 918 | 1986-03-27 | 78 |
Recalls for IOA devices
openFDA lists no recalls for product code IOA.
Frequently asked questions
What is FDA product code IOA?
IOA is the FDA product code for diathermy, microwave, for use in applying therapeutic deep heat. It is a Class II device, regulated under 21 CFR 890.5275 and reviewed by the Physical Medicine panel.
What device class is IOA?
Class II, regulation 21 CFR 890.5275. Typical premarket route: 510(k).
How long does a 510(k) take for product code IOA?
Across 4 cleared submissions the average was 308 days from receipt to decision (median 216).
Which companies have the most IOA clearances?
Cheung Laboratories, Inc. (1); Nemectron Medical, Inc. (1); Elmed, Inc. (1); Medical Microwave Research Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IOA
- Run a recall and safety report across every IOA manufacturer
- Watch product code IOA 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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