Data / Medical devices / Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat (ILX): 7 FDA-registered makers in 3 countries
7 establishments in 3 countries are registered with the FDA to make Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat (product code ILX, Class 2, 21 CFR 890.5290). 5 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 15 510(k) clearances under this code, the latest on December 18, 2024, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- ILX
- Device class
- 2
- Regulation
- 890.5290
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| China | 1 |
| Taiwan | 1 |
Makers of Diathermy, Shortwave, For Use Other Than 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 |
|---|---|---|---|---|---|---|---|---|
| Endonovo Therapeutics | Woodland Hills, CA, United States | Specification developer | 2 | July 27, 2012 | 0 | 0 | 0 | api.fda.gov |
| Orthocor Medical Inc. | Blaine, MN, United States | Manufacturer | 2 | December 18, 2024 | 0 | 0 | 0 | api.fda.gov |
| Bioelectronics Corporation | Jefferson, MD, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | June 28, 2019 | 0 | 0 | 0 | api.fda.gov |
| Hi-Dow Electron Technology (hefei) Inc., Ltd | Hefei Anhui, China | Manufacturer | 1 | December 15, 2020 | 0 | 0 | 0 | api.fda.gov |
| Regenesis Biomedical, Inc. | Scottsdale, AZ, United States | Specification developer | 1 | December 13, 2013 | 0 | 1 | 0 | api.fda.gov |
| Adm Tronics Unltd, Inc. | Northvale, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Well-Life Healthcare Limited | Jhonghe Taipei, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 18, 2024. 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.