Atlas FDA

EGJ

73 FDA 510(k) clearances · Product code

107 daysmedian time to decision
420 days90th percentile
73clearances measured

FDA profile

Official device name
Device, Iontophoresis, Other Uses
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5525
Medical specialty
Physical Medicine
Adverse events (MAUDE)
2006: 2 · 2008: 6 · 2009: 10 · 2010: 21 · 2011: 9 · 2012: 8
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
STOPWET iontophoresis apparatus (SW01) (K242041)Taiwan Medical Electronics Co., Ltd.2025-04-01
Hidroxa SE30 (K241267)Hidroxa Medical AB2024-10-17
Iontophoresis Electrodes (K232020)Top-Rank Health Care Co., Ltd.2023-10-16
Dermadry (K192749)Dermadry Laboratories, Inc.2020-02-10
Saalio (K191436)Saalmann Medical GmbH & Co. KG2019-10-18
Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE (K170835)Hightech Development2018-06-15
IontoDC (K170291)Soterix Medical, Inc.2017-05-01
TULA Iontophoresis System with Earset (K150453)Acclarent, Inc.2015-05-20
HIDREX PSP1000 (K133033)Hidrex GmbH2015-04-08
ACTIVAPATCH ET IONTOPHORESIS PATCH (K132832)Activatek, Inc.2014-02-13
TULA IONTOPHORESIS SYSTEM (K110636)Acclarent, Inc.2011-06-16
ACTHYDERM (K083016)Microlab Americas, Inc.2009-06-16
ACTIVAPATCH (K091326)Activatek, Inc.2009-05-27
COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D (K080580)Axelgaard Mfg. Co., Ltd.2008-06-18
IONTOPHORESIS SYSTEM (K073276)Acclarent, Inc.2008-03-05
HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM (K072946)Empi2007-11-16
DUPEL TRANSPORT IONTOPHORESIS SYSTEM (K070427)Empi2007-05-14
MESODERM (K061849)Aa Advanced Technology, Inc.2007-04-30
ERCHONIA IOTO_240 (K062792)Erchonia Medical, Inc.2007-03-01
CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE (K063465)Iomed, Inc.2007-02-28
TRIVARION BUFFERED IONTOPHORESIS ELECTRODE SYSTEM (K061522)Activatek, Inc.2006-08-01
DYNATRON ION IONTOPHORESIS ELECTRODE (K060814)Dynatronics Corp.2006-06-14
COMFORT/IO IONTOPHORESIS ELECTRODES (K060579)Pepin Mfg., Inc.2006-04-20
MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE (K060236)Iomed, Inc.2006-03-31
NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE (K052019)North Coast Medical, Inc.2005-11-04
DYNATRON IBOX IONTOPHORESIS DEVICE (K043047)Dynatronics Corp.2005-01-07
TRANSDERM IONTO SYSTEM, MK 2 (K042590)Mattioli Engineering Corp.2004-10-14
MEDICAL ADHESIVEONLINE, LLC. IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 23001, 23002, 23003, 23004, AND 24001 (K041101)Medical Adhesiveonline, LLC2004-07-07
NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401, 201-402, 201-403 AND 201-405 (K040495)Naimco, Inc.2004-04-22
TRSANSDERM IONTO SYSTEM (K032968)Mattioli Engineering Corp.2003-12-02
E-STRIP (K031769)Eemso, Inc.2003-10-14
SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7 (K031053)Selectivemed Components, Inc.2003-05-20
MINIPHYSIONIZER 2.0 AND ELECTRODES (K022950)Physion, Inc.2003-04-18
EMPI ACTION PATCH IONTOPHORESIS SYSTEM (K030395)Empi2003-04-08
MEDION 6000 (K020476)Selectivemed Components, Inc.2002-05-03
IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE) (K000574)Wr Medical Electronics Co.2000-08-09
IO-DRIVE (K993081)Selectivemed Components, Inc.2000-03-03
IONTOPATCH (K992708)Birch Point Medical, Inc.2000-02-01
DUPEL IONTOPHORESIS SYSTEM (K991991)Empi1999-09-10
PHORESOR II,MODEL PM900 (K982668)Iomed, Inc.1999-03-02
DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE (K983484)Empi1998-12-28
DUPEL II BUFFERED IONTOPHORESIS ELECTRODES (K970491)Empi1997-05-30
MD-1A GALVANIC UNIT (K964208)R. A. Fischer Co. Corp.1997-04-30
IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II (K946337)Skylark Device Co., Ltd.1995-12-20
DYNAPHOR(TM) TWO (K935868)Maxxim Medical1995-03-15
RH-801/GS MODEL TRANSQ(R)1 (K932621)Iomed, Inc.1994-07-26
PHORESOR II AUTO, MODEL PM800 MODIFICATION (K934335)Iomed, Inc.1994-07-26
RH-806/GS MODEL TRANSQ(R)2 (K932620)Iomed, Inc.1994-07-26
DUPEL IONTOPHORESIS DEVICE (K915444)Empi1994-07-15
MICROPHOR (K913601)Life-Tech Intl., Inc.1994-07-15
RH-801, MODEL TRANSQ (K925806)Iomed, Inc.1994-07-14
RH-806, MODEL TRANSQ (K925800)Iomed, Inc.1994-07-14
IONTOPHORESIS DEVICE, MODIFICATION (K914621)Iomed, Inc.1991-12-20
TRANSQ 2 (K914264)Iomed, Inc.1991-12-20
TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3 (K912015)Empi1991-11-15
TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODES MDL. 2 (K912014)Empi1991-10-28
IONTOPHORESIS DEVICE (K903093)Empi1990-10-11
MD-2 IONTOPHORESIS UNIT (K895365)R. A. Fischer Co. Corp.1990-06-26
IONTOPHORESIS DEVICE - ELECTRODE RH 800 (K896444)Iomed, Inc.1990-05-10
NEOPHOR-MC (K900363)L.S. Scientific1990-04-25
TBD IONTOPHORESIS ELECTRODE (K896703)Empi1990-02-26
DYNAPHOR(TM) 101, IONTOPHORESIS DEVICE (K894549)Henley Intl.1990-02-09
XOMED IONESTHETIZER(TM) (K884834)Xomed, Inc.1989-02-15
MEDITRODE KIT (K882554)Life-Tech Intl., Inc.1988-12-23
MODIFIED USE FOR MODEL 6110A IONTOPHORETIC APPLI. (K871869)Life-Tech Intl., Inc.1987-08-11
PHORESOR II (TM), MODEL PM700 (K872040)Motion Control, Inc.1987-08-04
MODEL 6110 IONTOPHORETIC APPLICATOR (K863166)Life-Tech Intl., Inc.1987-03-04
SUBDERM TM (K853635)General Medical Co.1985-12-20
LOGIKAL LONTOPHORESIS UNIT -ANESTHESIA INOTOPHORES (K850508)Kal Life Systems1985-05-15
SANTA BARBARA MEDCO-LANTOPHORETIC APPLIC (K842483)Santa Barbara Medco, Inc.1984-08-31
DRIONIC (K831320)General Medical Co.1983-07-19
IONTOPHORESIS SYSTEM MODULE, DM 500 (K770717)Sorensen Research1977-08-15
DESENSITRON (K771130)Parker Laboratories, Inc.1977-07-15

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