Data / Medical devices / Device, Iontophoresis, Other Uses
Device, Iontophoresis, Other Uses (EGJ): 16 FDA-registered makers in 7 countries
16 establishments in 7 countries are registered with the FDA to make Device, Iontophoresis, Other Uses (product code EGJ, Class 2, 21 CFR 890.5525). 12 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 73 510(k) clearances under this code, the latest on April 1, 2025, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EGJ
- Device class
- 2
- Regulation
- 890.5525
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Germany | 2 |
| Canada | 1 |
| Italy | 1 |
| China | 1 |
| Taiwan | 1 |
| South Korea | 1 |
Makers of Device, Iontophoresis, Other Uses
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 |
|---|---|---|---|---|---|---|---|---|
| Djo, LLC | Carlsbad, CA, United States | Specification developer | 16 | November 16, 2007 | 0 | 0 | 0 | api.fda.gov |
| North Coast Medical, Inc. | Morgan Hill, CA, United States | Manufacturer | 4 | February 13, 2014 | 0 | 0 | 0 | api.fda.gov |
| WR Medical Electronics Co. | Maplewood, MN, United States | Manufacturer | 3 | August 9, 2000 | 0 | 0 | 0 | api.fda.gov |
| Axelgaard MFG. Co., Ltd. | Fallbrook, CA, United States | Manufacturer | 1 | June 18, 2008 | 0 | 0 | 0 | api.fda.gov |
| Dermadry Laboratories Inc. | Montreal Quebec, Canada | Manufacturer | 1 | February 10, 2020 | 0 | 0 | 0 | api.fda.gov |
| General Medical Co. | Jacksonville, FL, United States | Complaint file establishment, Manufacturer | 1 | July 19, 1983 | 0 | 0 | 0 | api.fda.gov |
| Hidrex GMBH | Heiligenhaus North Rhine-Westphalia, Germany | Manufacturer | 1 | April 8, 2015 | 0 | 1 | 0 | api.fda.gov |
| LTS Therapy Systems, LLC | West St Paul, MN, United States | Manufacturer | 1 | February 1, 2000 | 0 | 2 | 0 | api.fda.gov |
| Mattioli Engineering Italia SRL | Calenzano Firenze, Italy | Specification developer | 1 | October 14, 2004 | 0 | 0 | 0 | api.fda.gov |
| Saalmann Medical GMBH & Co. KG | Bad Oeynhausen North Rhine-Westphalia, Germany | Manufacturer | 1 | October 18, 2019 | 0 | 0 | 0 | api.fda.gov |
| Soterix Medical,inc. | Woodbridge, NJ, United States | Manufacturer | 1 | May 1, 2017 | 0 | 0 | 0 | api.fda.gov |
| Top-rank Health Care Co.,Ltd. | Shaoxing Zhejiang, China | Manufacturer | 1 | October 16, 2023 | 0 | 0 | 0 | api.fda.gov |
| Clearlake-Tech Inc | Clear Lake, SD, United States | Contract manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health | Wabasha, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wandy Rubber Industrial Co., Ltd | New Taipei City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| WEERO Co., Ltd. | Suwon-si,Gyeonggi-do, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 1, 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.