FDA 510(k) Applications for Medical Device Product Code "EGJ"
(Device, Iontophoresis, Other Uses)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K061849 | AA ADVANCED TECHNOLOGY INC. | MESODERM | 04/30/2007 |
| K073276 | ACCLARENT, INC. | IONTOPHORESIS SYSTEM | 03/05/2008 |
| K110636 | ACCLARENT, INC. | TULA IONTOPHORESIS SYSTEM | 06/16/2011 |
| K150453 | ACCLARENT, INC. | TULA Iontophoresis System with Earset | 05/20/2015 |
| K061522 | ACTIVA TEK INC | TRIVARION BUFFERED IONTOPHORESIS ELECTRODE SYSTEM | 08/01/2006 |
| K091326 | ACTIVATEK INC. | ACTIVAPATCH | 05/27/2009 |
| K132832 | ACTIVATEK INC. | ACTIVAPATCH ET IONTOPHORESIS PATCH | 02/13/2014 |
| K080580 | AXELGAARD MFG. CO., LTD. | COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D | 06/18/2008 |
| K992708 | BIRCH POINT MEDICAL, INC. | IONTOPATCH | 02/01/2000 |
| K192749 | Dermadry Laboratories inc. | Dermadry | 02/10/2020 |
| K043047 | DYNATRONICS CORP. | DYNATRON IBOX IONTOPHORESIS DEVICE | 01/07/2005 |
| K060814 | DYNATRONICS CORP. | DYNATRON ION IONTOPHORESIS ELECTRODE | 06/14/2006 |
| K031769 | EEMSO, INC. | E-STRIP | 10/14/2003 |
| K983484 | EMPI | DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE | 12/28/1998 |
| K970491 | EMPI | DUPEL II BUFFERED IONTOPHORESIS ELECTRODES | 05/30/1997 |
| K991991 | EMPI | DUPEL IONTOPHORESIS SYSTEM | 09/10/1999 |
| K070427 | EMPI | DUPEL TRANSPORT IONTOPHORESIS SYSTEM | 05/14/2007 |
| K030395 | EMPI | EMPI ACTION PATCH IONTOPHORESIS SYSTEM | 04/08/2003 |
| K072946 | EMPI | HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM | 11/16/2007 |
| K062792 | ERCHONIA MEDICAL, INC. | ERCHONIA IOTO_240 | 03/01/2007 |
| K133033 | HIDREX GMBH | HIDREX PSP1000 | 04/08/2015 |
| K170835 | Hightech Development | Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE | 06/15/2018 |
| K063465 | IOMED, INC. | CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE | 02/28/2007 |
| K060236 | IOMED, INC. | MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE | 03/31/2006 |
| K982668 | IOMED, INC. | PHORESOR II,MODEL PM900 | 03/02/1999 |
| K042590 | MATTIOLI ENGINEERING CORP. | TRANSDERM IONTO SYSTEM, MK 2 | 10/14/2004 |
| K032968 | MATTIOLI ENGINEERING CORP. | TRSANSDERM IONTO SYSTEM | 12/02/2003 |
| K041101 | MEDICAL ADHESIVEONLINE, LLC. | MEDICAL ADHESIVEONLINE, LLC. IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 23001, 23002, 23003, 23004, AND 24001 | 07/07/2004 |
| K083016 | MICROLAB AMERICAS INC | ACTHYDERM | 06/16/2009 |
| K040495 | NAIMCO, INC. | NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401, 201-402, 201-403 AND 201-405 | 04/22/2004 |
| K052019 | NORTH COAST MEDICAL, INC. | NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE | 11/04/2005 |
| K060579 | PEPIN MFG., INC. | COMFORT/IO IONTOPHORESIS ELECTRODES | 04/20/2006 |
| K022950 | PHYSION, INC. | MINIPHYSIONIZER 2.0 AND ELECTRODES | 04/18/2003 |
| K964208 | R. A. FISCHER CO. CORP. | MD-1A GALVANIC UNIT | 04/30/1997 |
| K191436 | Saalmann medical GmbH & Co. KG | Saalio | 10/18/2019 |
| K993081 | SELECTIVE MED COMPONENTS, INC. | IO-DRIVE | 03/03/2000 |
| K020476 | SELECTIVE MED COMPONENTS, INC. | MEDION 6000 | 05/03/2002 |
| K031053 | SELECTIVE MED COMPONENTS, INC. | SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7 | 05/20/2003 |
| K170291 | SOTERIX MEDICAL,INC. | IontoDC | 05/01/2017 |
| K000574 | WR MEDICAL ELECTRONICS CO. | IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE) | 08/09/2000 |
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