Data / Medical devices / Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat (PFW): 7 FDA-registered makers in 5 countries
7 establishments in 5 countries are registered with the FDA to make Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat (product code PFW, Class 2, 21 CFR 890.5300). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on April 28, 2026, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- PFW
- Device class
- 2
- Regulation
- 890.5300
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| China | 2 |
| Israel | 1 |
| India | 1 |
| Cambodia | 1 |
Makers of Stationary Ultrasonic Diathermy Device 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 |
|---|---|---|---|---|---|---|---|---|
| ZetrOZ Systems | Trumbull, CT, United States | Manufacturer | 5 | April 28, 2026 | 0 | 0 | 0 | api.fda.gov |
| Nanovibronix, Ltd. | NESHER Haifa, Israel | Specification developer | 1 | August 22, 2008 | 0 | 0 | 0 | api.fda.gov |
| Syrma Johari MedTech Limited | Jodhpur Rajasthan, India | Manufacturer | 1 | March 12, 2008 | 0 | 0 | 0 | api.fda.gov |
| Grandway Technology (shenzhen) Limited | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| JKH Health Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Just Keep Healthy Co., Ltd. | Samkkei Munichay District Kampong Speu, Cambodia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Manamed LLC | Denton, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 28, 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.