FDA product code IMJ: Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
IMJ is the FDA product code for diathermy, shortwave, for use in applying therapeutic deep heat. It is a Class II device, regulated under 21 CFR 890.5290 and reviewed by the Physical Medicine panel. FDA has cleared 45 510(k) submissions under IMJ, 4 in the last five years, from 32 different applicants. The average 510(k) review took 142 days (median 106); 268 days on average over the last three years. FDA has posted 1 recall for IMJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat |
| Device class | Class II |
| Regulation | 21 CFR 890.5290 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for IMJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 196 |
| 2019 | 1 | 147 |
| 2023 | 1 | 170 |
| 2025 | 2 | 268 |
| 2026 | 1 | 268 |
Compare with all 510(k) review times · Search every IMJ clearance
Top IMJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| BTL Industries, Inc. | 3 | 2026-06-12 |
| Rich-Mar Corp. | 3 | 1986-12-29 |
| Viatherm Therapeutics, LLC | 2 | 2025-11-05 |
| Mettler Electronics Corp. | 2 | 2004-10-08 |
| Selicor, Inc. | 2 | 2003-04-01 |
27 more applicants have IMJ clearances. See the full list in Caduvo.
Most recent IMJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252963 | BTL Industries, Inc. | BTL-899TT | 2026-06-12 | 268 |
| K250376 | Viatherm Therapeutics, LLC | ViVY | 2025-11-05 | 268 |
| K243112 | Enraf-Nonius, B.V. | Curapuls 670 | 2025-06-25 | 268 |
| K223620 | Regenesis Biomedical, Inc. | Reprieve by RegenesisTM | 2023-05-24 | 170 |
| K182363 | BTL Industries, Inc. | BTL-703 | 2019-01-24 | 147 |
Recalls for IMJ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-08-21.
Frequently asked questions
What is FDA product code IMJ?
IMJ is the FDA product code for diathermy, shortwave, for use in applying therapeutic deep heat. It is a Class II device, regulated under 21 CFR 890.5290 and reviewed by the Physical Medicine panel.
What device class is IMJ?
Class II, regulation 21 CFR 890.5290. Typical premarket route: 510(k).
How long does a 510(k) take for product code IMJ?
Across 45 cleared submissions the average was 142 days from receipt to decision (median 106).
Which companies have the most IMJ clearances?
BTL Industries, Inc. (3); Rich-Mar Corp. (3); Viatherm Therapeutics, LLC (2); Mettler Electronics Corp. (2); Selicor, Inc. (2).
Have IMJ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-08-21.
Next steps
- Run an FDA pathway report with predicate devices for product code IMJ
- Run a recall and safety report across every IMJ manufacturer
- Watch product code IMJ 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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