Data / Medical devices / Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat (IMJ): 13 FDA-registered makers in 6 countries
13 establishments in 6 countries are registered with the FDA to make Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat (product code IMJ, Class 2, 21 CFR 890.5290). 10 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 45 510(k) clearances under this code, the latest on June 12, 2026, and lists 1 recall event (0 Class I). FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- IMJ
- Device class
- 2
- Regulation
- 890.5290
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| United Kingdom | 1 |
| Mexico | 1 |
| Netherlands | 1 |
| China | 1 |
| Germany | 1 |
Makers of Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Ems Physio Ltd. | Irvine North Ayrshire, United Kingdom | Manufacturer | 2 | June 14, 2016 | 0 | 0 | 0 | api.fda.gov |
| Accelerated Care Plus Corp. | Reno, NV, United States | Repackager or relabeler, Specification developer | 1 | June 14, 2016 | 0 | 0 | 0 | api.fda.gov |
| DJ Orthopedics De Mexico, S.A. De C.V. | TIJUANA Baja California, Mexico | Manufacturer | 1 | March 18, 2009 | 0 | 0 | 0 | api.fda.gov |
| Djo, LLC | Carlsbad, CA, United States | Specification developer | 1 | March 18, 2009 | 0 | 0 | 0 | api.fda.gov |
| Enraf-Nonius B.V. | ROTTERDAM Zuid-Holland, Netherlands | Complaint file establishment, Manufacturer, Specification developer | 1 | June 25, 2025 | 0 | 0 | 0 | api.fda.gov |
| Mettler Electronics Corp. | Anaheim, CA, United States | Manufacturer | 1 | October 8, 2004 | 0 | 0 | 0 | api.fda.gov |
| Promedtek, Inc. | Scottsdale, AZ, United States | Repackager or relabeler, Specification developer | 1 | November 17, 2016 | 0 | 0 | 0 | api.fda.gov |
| Regenesis Biomedical, Inc. | Scottsdale, AZ, United States | Specification developer | 1 | May 24, 2023 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Dongdixin Technology Co., Ltd. | SHENZHEN Guangdong, China | Manufacturer | 1 | March 14, 2014 | 0 | 0 | 0 | api.fda.gov |
| Zimmer Medizinsysteme GMBH | NEU-ULM Bavaria, Germany | Manufacturer | 1 | November 14, 2016 | 0 | 0 | 0 | api.fda.gov |
| Amrex-Zetron, Inc. | Paramount, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hda Technology, Inc. | Lake Forest, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Velentium Medical | Richmond, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 12, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.