EGJ — Device, Iontophoresis, Other Uses Class II
FDA product code EGJ covers "Device, Iontophoresis, Other Uses", a Class II medical device regulated under 21 CFR 890.5525. Submissions are reviewed by the Physical Medicine panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EGJ
- Device Class
- Class II
- Regulation Number
- 890.5525
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242041 | taiwan medical electronics co | STOPWET iontophoresis apparatus (SW01) | April 1, 2025 |
| K241267 | hidroxa medical | Hidroxa SE30 | October 17, 2024 |
| K232020 | top-rank health care co | Iontophoresis Electrodes | October 16, 2023 |
| K192749 | dermadry laboratories | Dermadry | February 10, 2020 |
| K191436 | saalmann medical gmbh and co. kg | Saalio | October 18, 2019 |
| K170835 | hightech development | Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant | June 15, 2018 |
| K170291 | soterix medical | IontoDC | May 1, 2017 |
| K150453 | acclarent | TULA Iontophoresis System with Earset | May 20, 2015 |
| K133033 | hidrex | HIDREX PSP1000 | April 8, 2015 |
| K132832 | activatek | ACTIVAPATCH ET IONTOPHORESIS PATCH | February 13, 2014 |
| K110636 | acclarent | TULA IONTOPHORESIS SYSTEM | June 16, 2011 |
| K083016 | microlab americas | ACTHYDERM | June 16, 2009 |
| K091326 | activatek | ACTIVAPATCH | May 27, 2009 |
| K080580 | axelgaard mfg. co | COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MO | June 18, 2008 |
| K073276 | acclarent | IONTOPHORESIS SYSTEM | March 5, 2008 |
| K072946 | empi | HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM | November 16, 2007 |
| K070427 | empi | DUPEL TRANSPORT IONTOPHORESIS SYSTEM | May 14, 2007 |
| K061849 | aa advanced technology | MESODERM | April 30, 2007 |
| K062792 | erchonia medical | ERCHONIA IOTO_240 | March 1, 2007 |
| K063465 | iomed | CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE | February 28, 2007 |