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
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
K912015 EMPI TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3 11/15/1991
K912014 EMPI TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODES MDL. 2 10/28/1991
K062792 ERCHONIA MEDICAL, INC. ERCHONIA IOTO_240 03/01/2007
K831320 GENERAL MEDICAL CO. DRIONIC 07/19/1983
K894549 HENLEY INTL. DYNAPHOR(TM) 101, IONTOPHORESIS DEVICE 02/09/1990
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
K914621 IOMED, INC. IONTOPHORESIS DEVICE, MODIFICATION 12/20/1991
K060236 IOMED, INC. MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE 03/31/2006
K934335 IOMED, INC. PHORESOR II AUTO, MODEL PM800 MODIFICATION 07/26/1994
K982668 IOMED, INC. PHORESOR II,MODEL PM900 03/02/1999
K925806 IOMED, INC. RH-801, MODEL TRANSQ 07/14/1994
K932621 IOMED, INC. RH-801/GS MODEL TRANSQ(R)1 07/26/1994
K925800 IOMED, INC. RH-806, MODEL TRANSQ 07/14/1994
K932620 IOMED, INC. RH-806/GS MODEL TRANSQ(R)2 07/26/1994
K914264 IOMED, INC. TRANSQ 2 12/20/1991
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
K771130 PARKER LABORATORIES, INC. DESENSITRON 07/15/1977
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
K895365 R. A. FISCHER CO. CORP. MD-2 IONTOPHORESIS UNIT 06/26/1990
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
K946337 SKYLARK DEVICE CO., LTD. IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II 12/20/1995
K770717 SORENSEN RESEARCH IONTOPHORESIS SYSTEM MODULE, DM 500 08/15/1977
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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