Data / Medical devices / Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (IMG): 17 FDA-registered makers in 9 countries
17 establishments in 9 countries are registered with the FDA to make Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (product code IMG, Class 2, 21 CFR 890.5860). 12 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 55 510(k) clearances under this code, the latest on October 7, 2025, and lists 1 recall event (0 Class I). FDA data exported November 3, 2026.
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- Product code
- IMG
- Device class
- 2
- Regulation
- 890.5860
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| China | 4 |
| Mexico | 1 |
| France | 1 |
| Netherlands | 1 |
| India | 1 |
| Germany | 1 |
| Taiwan | 1 |
| Czechia | 1 |
Makers of Stimulator, Ultrasound And Muscle, 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 |
|---|---|---|---|---|---|---|---|---|
| Shenzhen Dongdixin Technology Co., Ltd. | SHENZHEN Guangdong, China | Manufacturer | 3 | November 13, 2015 | 0 | 0 | 0 | api.fda.gov |
| DJ Orthopedics De Mexico, S.A. De C.V. | TIJUANA Baja California, Mexico | Manufacturer | 2 | April 12, 2004 | 0 | 0 | 0 | api.fda.gov |
| Djo France SAS | MOUGUERRE Pyrenees-Atlantiques, France | Manufacturer, Specification developer | 2 | April 12, 2004 | 0 | 0 | 0 | api.fda.gov |
| Djo, LLC | Carlsbad, CA, United States | Manufacturer, Specification developer | 2 | April 12, 2004 | 0 | 0 | 0 | api.fda.gov |
| Accelerated Care Plus Corp. | Reno, NV, United States | Specification developer | 1 | August 26, 2016 | 0 | 0 | 0 | api.fda.gov |
| Drive Northpoint, LLC | Palmetto, GA, United States | Manufacturer | 1 | November 13, 2015 | 0 | 0 | 0 | api.fda.gov |
| Enraf-Nonius B.V. | ROTTERDAM Zuid-Holland, Netherlands | Complaint file establishment, Manufacturer, Specification developer | 1 | August 26, 2016 | 0 | 0 | 0 | api.fda.gov |
| Rohrer Aesthetics, Inc. | Homewood, AL, United States | Complaint file establishment, Specification developer | 1 | November 3, 2011 | 0 | 0 | 0 | api.fda.gov |
| Syrma Johari MedTech Limited | Jodhpur Rajasthan, India | Manufacturer | 1 | March 17, 2011 | 0 | 0 | 0 | api.fda.gov |
| Xemis Medical Technology (shenzhen) Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 1 | October 7, 2025 | 0 | 0 | 0 | api.fda.gov |
| Zimmer Medizinsysteme GMBH | NEU-ULM Bavaria, Germany | Manufacturer | 1 | August 7, 2012 | 0 | 0 | 0 | api.fda.gov |
| Zmi Electronics Ltd. | Kaohsiung, Taiwan | Contract manufacturer, Manufacturer | 1 | November 1, 1988 | 0 | 0 | 0 | api.fda.gov |
| Amrex-Zetron, Inc. | Paramount, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing Syntech Laser Co., Ltd. | Beijing, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clearlake-Tech Inc | Clear Lake, SD, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Connectronics S.R.O. | Kladno, Czechia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ebulent Optronics (shenzhen) Ltd | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 7, 2025. 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.