Device, Iontophoresis, Other Uses

FDA product code EGJ · 70 cleared devices

Class 2 Physical Medicine

Regulation: 21 CFR 890.5525
Review panel: PM
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-07-15 – 2025-04-01

EGJ 2025-04-01

STOPWET iontophoresis apparatus (SW01)

Applicant Taiwan Medical Electronics Co., Ltd.

K number K242041

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EGJ 2024-10-17

Hidroxa SE30

Applicant Hidroxa Medical AB

K number K241267

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EGJ 2023-10-16

Iontophoresis Electrodes

Applicant Top-Rank Health Care Co., Ltd.

K number K232020

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EGJ 2020-02-10

Dermadry

Applicant Dermadry Laboratories, Inc.

K number K192749

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EGJ 2019-10-18

Saalio

Applicant Saalmann Medical GmbH & Co. KG

K number K191436

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EGJ 2018-06-15

Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE

Applicant Hightech Development

K number K170835

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EGJ 2017-05-01

IontoDC

Applicant Soterix Medical, Inc.

K number K170291

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EGJ 2011-06-16

TULA IONTOPHORESIS SYSTEM

Applicant Acclarent, Inc.

K number K110636

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EGJ 2009-06-16

ACTHYDERM

Applicant Microlab Americas, Inc.

K number K083016

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EGJ 2009-05-27

ACTIVAPATCH

Applicant Activatek, Inc.

K number K091326

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EGJ 2008-06-18

COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D

Applicant Axelgaard Mfg. Co., Ltd.

K number K080580

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EGJ 2008-03-05

IONTOPHORESIS SYSTEM

Applicant Acclarent, Inc.

K number K073276

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EGJ 2007-11-16

HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM

Applicant Empi

K number K072946

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EGJ 2007-05-14

DUPEL TRANSPORT IONTOPHORESIS SYSTEM

Applicant Empi

K number K070427

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EGJ 2007-04-30

MESODERM

Applicant Aa Advanced Technology, Inc.

K number K061849

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EGJ 2007-03-01

ERCHONIA IOTO_240

Applicant Erchonia Medical, Inc.

K number K062792

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EGJ 2007-02-28

CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE

Applicant Iomed, Inc.

K number K063465

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EGJ 2006-08-01

TRIVARION BUFFERED IONTOPHORESIS ELECTRODE SYSTEM

Applicant Activatek, Inc.

K number K061522

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EGJ 2006-06-14

DYNATRON ION IONTOPHORESIS ELECTRODE

Applicant Dynatronics Corp.

K number K060814

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EGJ 2006-04-20

COMFORT/IO IONTOPHORESIS ELECTRODES

Applicant Pepin Mfg., Inc.

K number K060579

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EGJ 2006-03-31

MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE

Applicant Iomed, Inc.

K number K060236

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EGJ 2005-11-04

NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE

Applicant North Coast Medical, Inc.

K number K052019

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EGJ 2005-01-07

DYNATRON IBOX IONTOPHORESIS DEVICE

Applicant Dynatronics Corp.

K number K043047

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EGJ 2004-10-14

TRANSDERM IONTO SYSTEM, MK 2

Applicant Mattioli Engineering Corp.

K number K042590

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EGJ 2004-07-07

MEDICAL ADHESIVEONLINE, LLC. IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 23001, 23002, 23003, 23004, AND 24001

Applicant Medical Adhesiveonline, LLC

K number K041101

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EGJ 2004-04-22

NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401, 201-402, 201-403 AND 201-405

Applicant Naimco, Inc.

K number K040495

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EGJ 2003-12-02

TRSANSDERM IONTO SYSTEM

Applicant Mattioli Engineering Corp.

K number K032968

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EGJ 2003-10-14

E-STRIP

Applicant Eemso, Inc.

K number K031769

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EGJ 2003-05-20

SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7

Applicant Selectivemed Components, Inc.

K number K031053

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EGJ 2003-04-18

MINIPHYSIONIZER 2.0 AND ELECTRODES

Applicant Physion, Inc.

K number K022950

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EGJ 2003-04-08

EMPI ACTION PATCH IONTOPHORESIS SYSTEM

Applicant Empi

K number K030395

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EGJ 2002-05-03

MEDION 6000

Applicant Selectivemed Components, Inc.

K number K020476

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EGJ 2000-08-09

IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE)

Applicant Wr Medical Electronics Co.

K number K000574

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EGJ 2000-03-03

IO-DRIVE

Applicant Selectivemed Components, Inc.

K number K993081

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EGJ 2000-02-01

IONTOPATCH

Applicant Birch Point Medical, Inc.

K number K992708

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EGJ 1999-09-10

DUPEL IONTOPHORESIS SYSTEM

Applicant Empi

K number K991991

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EGJ 1999-03-02

PHORESOR II,MODEL PM900

Applicant Iomed, Inc.

K number K982668

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EGJ 1998-12-28

DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE

Applicant Empi

K number K983484

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EGJ 1997-05-30

DUPEL II BUFFERED IONTOPHORESIS ELECTRODES

Applicant Empi

K number K970491

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EGJ 1997-04-30

MD-1A GALVANIC UNIT

Applicant R. A. Fischer Co. Corp.

K number K964208

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EGJ 1995-12-20

IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II

Applicant Skylark Device Co., Ltd.

K number K946337

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EGJ 1995-03-15

DYNAPHOR(TM) TWO

Applicant Maxxim Medical

K number K935868

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EGJ 1994-07-26

PHORESOR II AUTO, MODEL PM800 MODIFICATION

Applicant Iomed, Inc.

K number K934335

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EGJ 1994-07-26

RH-801/GS MODEL TRANSQ(R)1

Applicant Iomed, Inc.

K number K932621

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EGJ 1994-07-26

RH-806/GS MODEL TRANSQ(R)2

Applicant Iomed, Inc.

K number K932620

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EGJ 1994-07-15

DUPEL IONTOPHORESIS DEVICE

Applicant Empi

K number K915444

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EGJ 1994-07-15

MICROPHOR

Applicant Life-Tech Intl., Inc.

K number K913601

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EGJ 1994-07-14

RH-801, MODEL TRANSQ

Applicant Iomed, Inc.

K number K925806

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EGJ 1994-07-14

RH-806, MODEL TRANSQ

Applicant Iomed, Inc.

K number K925800

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EGJ 1991-12-20

IONTOPHORESIS DEVICE, MODIFICATION

Applicant Iomed, Inc.

K number K914621

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EGJ 1991-12-20

TRANSQ 2

Applicant Iomed, Inc.

K number K914264

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EGJ 1991-11-15

TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3

Applicant Empi

K number K912015

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EGJ 1991-10-28

TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODES MDL. 2

Applicant Empi

K number K912014

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EGJ 1990-10-11

IONTOPHORESIS DEVICE

Applicant Empi

K number K903093

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EGJ 1990-06-26

MD-2 IONTOPHORESIS UNIT

Applicant R. A. Fischer Co. Corp.

K number K895365

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EGJ 1990-05-10

IONTOPHORESIS DEVICE - ELECTRODE RH 800

Applicant Iomed, Inc.

K number K896444

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EGJ 1990-04-25

NEOPHOR-MC

Applicant L.S. Scientific

K number K900363

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EGJ 1990-02-26

TBD IONTOPHORESIS ELECTRODE

Applicant Empi

K number K896703

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EGJ 1990-02-09

DYNAPHOR(TM) 101, IONTOPHORESIS DEVICE

Applicant Henley Intl.

K number K894549

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EGJ 1989-02-15

XOMED IONESTHETIZER(TM)

Applicant Xomed, Inc.

K number K884834

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EGJ 1988-12-23

MEDITRODE KIT

Applicant Life-Tech Intl., Inc.

K number K882554

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EGJ 1987-08-11

MODIFIED USE FOR MODEL 6110A IONTOPHORETIC APPLI.

Applicant Life-Tech Intl., Inc.

K number K871869

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EGJ 1987-08-04

PHORESOR II (TM), MODEL PM700

Applicant Motion Control, Inc.

K number K872040

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EGJ 1987-03-04

MODEL 6110 IONTOPHORETIC APPLICATOR

Applicant Life-Tech Intl., Inc.

K number K863166

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EGJ 1985-12-20

SUBDERM TM

Applicant General Medical Co.

K number K853635

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EGJ 1985-05-15

LOGIKAL LONTOPHORESIS UNIT -ANESTHESIA INOTOPHORES

Applicant Kal Life Systems

K number K850508

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EGJ 1984-08-31

SANTA BARBARA MEDCO-LANTOPHORETIC APPLIC

Applicant Santa Barbara Medco, Inc.

K number K842483

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EGJ 1983-07-19

DRIONIC

Applicant General Medical Co.

K number K831320

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EGJ 1977-08-15

IONTOPHORESIS SYSTEM MODULE, DM 500

Applicant Sorensen Research

K number K770717

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EGJ 1977-07-15

DESENSITRON

Applicant Parker Laboratories, Inc.

K number K771130

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