Product Code: EGJ FDA class 2 21 CFR 890.5525

Device, Iontophoresis, Other Uses

Physical Medicine

The Iontophoresis Device for Other Uses is a physical medicine device that uses a low-level electrical current to drive charged therapeutic agents (such as analgesics or anti-inflammatory medications) through intact skin into underlying tissues for localized drug delivery without injection. This particular product code covers iontophoresis applications outside of specific primary indications. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is EGJ and the applicable regulation is 21 CFR 890.5525, under the Physical Medicine medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: EGJ
Device Class: FDA class 2
Regulation Number: 890.5525
Medical Specialty: Physical Medicine
Review Panel: PM
Submission Type: 1

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 73 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K242041	STOPWET iontophoresis apparatus (SW01)	Apr 01, 2025	Substantially Equivalent	Taiwan Medical Electronics Co., Ltd.
K241267	Hidroxa SE30	Oct 17, 2024	Substantially Equivalent	Hidroxa Medical AB
K232020	Iontophoresis Electrodes	Oct 16, 2023	Substantially Equivalent	Top-Rank Health Care Co., Ltd.
K192749	Dermadry	Feb 10, 2020	Substantially Equivalent	Dermadry Laboratories, Inc.
K191436	Saalio	Oct 18, 2019	Substantially Equivalent	Saalmann Medical GmbH & Co. KG
K170835	Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE	Jun 15, 2018	Substantially Equivalent	Hightech Development
K170291	IontoDC	May 01, 2017	Substantially Equivalent	Soterix Medical, Inc.
K150453	TULA Iontophoresis System with Earset	May 20, 2015	Substantially Equivalent	Acclarent, Inc.
K133033	HIDREX PSP1000	Apr 08, 2015	Substantially Equivalent	Hidrex GmbH
K132832	ACTIVAPATCH ET IONTOPHORESIS PATCH	Feb 13, 2014	Substantially Equivalent	Activatek, Inc.
K110636	TULA IONTOPHORESIS SYSTEM	Jun 16, 2011	Substantially Equivalent	Acclarent, Inc.
K083016	ACTHYDERM	Jun 16, 2009	Substantially Equivalent	Microlab Americas, Inc.
K091326	ACTIVAPATCH	May 27, 2009	Substantially Equivalent	Activatek, Inc.
K080580	COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D	Jun 18, 2008	Substantially Equivalent	Axelgaard Mfg. Co., Ltd.
K073276	IONTOPHORESIS SYSTEM	Mar 05, 2008	Substantially Equivalent	Acclarent, Inc.
K072946	HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM	Nov 16, 2007	Substantially Equivalent	Empi
K070427	DUPEL TRANSPORT IONTOPHORESIS SYSTEM	May 14, 2007	Substantially Equivalent	Empi
K061849	MESODERM	Apr 30, 2007	Substantially Equivalent	Aa Advanced Technology, Inc.
K062792	ERCHONIA IOTO_240	Mar 01, 2007	Substantially Equivalent	Erchonia Medical, Inc.
K063465	CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE	Feb 28, 2007	Substantially Equivalent	Iomed, Inc.
K061522	TRIVARION BUFFERED IONTOPHORESIS ELECTRODE SYSTEM	Aug 01, 2006	Substantially Equivalent	Activatek, Inc.
K060814	DYNATRON ION IONTOPHORESIS ELECTRODE	Jun 14, 2006	Substantially Equivalent	Dynatronics Corp.
K060579	COMFORT/IO IONTOPHORESIS ELECTRODES	Apr 20, 2006	Substantially Equivalent	Pepin Mfg., Inc.
K060236	MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE	Mar 31, 2006	Substantially Equivalent	Iomed, Inc.
K052019	NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE	Nov 04, 2005	Substantially Equivalent	North Coast Medical, Inc.
K043047	DYNATRON IBOX IONTOPHORESIS DEVICE	Jan 07, 2005	Unknown	Dynatronics Corp.
K042590	TRANSDERM IONTO SYSTEM, MK 2	Oct 14, 2004	Substantially Equivalent	Mattioli Engineering Corp.
K041101	MEDICAL ADHESIVEONLINE, LLC. IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 23001, 23002, 23003, 23004, AND 24001	Jul 07, 2004	Substantially Equivalent	Medical Adhesiveonline, LLC
K040495	NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401, 201-402, 201-403 AND 201-405	Apr 22, 2004	Substantially Equivalent	Naimco, Inc.
K032968	TRSANSDERM IONTO SYSTEM	Dec 02, 2003	Substantially Equivalent	Mattioli Engineering Corp.
K031769	E-STRIP	Oct 14, 2003	Substantially Equivalent for Some Indications	Eemso, Inc.
K031053	SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7	May 20, 2003	Substantially Equivalent	Selectivemed Components, Inc.
K022950	MINIPHYSIONIZER 2.0 AND ELECTRODES	Apr 18, 2003	Substantially Equivalent	Physion, Inc.
K030395	EMPI ACTION PATCH IONTOPHORESIS SYSTEM	Apr 08, 2003	Substantially Equivalent	Empi
K020476	MEDION 6000	May 03, 2002	Substantially Equivalent	Selectivemed Components, Inc.
K000574	IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE)	Aug 09, 2000	Substantially Equivalent	Wr Medical Electronics Co.
K993081	IO-DRIVE	Mar 03, 2000	Substantially Equivalent	Selectivemed Components, Inc.
K992708	IONTOPATCH	Feb 01, 2000	Substantially Equivalent	Birch Point Medical, Inc.
K991991	DUPEL IONTOPHORESIS SYSTEM	Sep 10, 1999	Substantially Equivalent	Empi
K982668	PHORESOR II,MODEL PM900	Mar 02, 1999	Substantially Equivalent	Iomed, Inc.
K983484	DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE	Dec 28, 1998	Substantially Equivalent	Empi
K970491	DUPEL II BUFFERED IONTOPHORESIS ELECTRODES	May 30, 1997	Substantially Equivalent	Empi
K964208	MD-1A GALVANIC UNIT	Apr 30, 1997	Substantially Equivalent	R. A. Fischer Co. Corp.
K946337	IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II	Dec 20, 1995	Substantially Equivalent	Skylark Device Co., Ltd.
K935868	DYNAPHOR(TM) TWO	Mar 15, 1995	Substantially Equivalent	Maxxim Medical
K934335	PHORESOR II AUTO, MODEL PM800 MODIFICATION	Jul 26, 1994	Substantially Equivalent	Iomed, Inc.
K932621	RH-801/GS MODEL TRANSQ(R)1	Jul 26, 1994	Substantially Equivalent	Iomed, Inc.
K932620	RH-806/GS MODEL TRANSQ(R)2	Jul 26, 1994	Substantially Equivalent	Iomed, Inc.
K915444	DUPEL IONTOPHORESIS DEVICE	Jul 15, 1994	Substantially Equivalent	Empi
K913601	MICROPHOR	Jul 15, 1994	Substantially Equivalent	Life-Tech Intl., Inc.
K925806	RH-801, MODEL TRANSQ	Jul 14, 1994	Substantially Equivalent	Iomed, Inc.
K925800	RH-806, MODEL TRANSQ	Jul 14, 1994	Substantially Equivalent	Iomed, Inc.
K914621	IONTOPHORESIS DEVICE, MODIFICATION	Dec 20, 1991	Unknown	Iomed, Inc.
K914264	TRANSQ 2	Dec 20, 1991	Unknown	Iomed, Inc.
K912015	TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3	Nov 15, 1991	Substantially Equivalent	Empi
K912014	TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODES MDL. 2	Oct 28, 1991	Substantially Equivalent	Empi
K903093	IONTOPHORESIS DEVICE	Oct 11, 1990	Unknown	Empi
K895365	MD-2 IONTOPHORESIS UNIT	Jun 26, 1990	Unknown	R. A. Fischer Co. Corp.
K896444	IONTOPHORESIS DEVICE - ELECTRODE RH 800	May 10, 1990	Unknown	Iomed, Inc.
K900363	NEOPHOR-MC	Apr 25, 1990	Unknown	L.S. Scientific
K896703	TBD IONTOPHORESIS ELECTRODE	Feb 26, 1990	Unknown	Empi
K894549	DYNAPHOR(TM) 101, IONTOPHORESIS DEVICE	Feb 09, 1990	Unknown	Henley Intl.
K884834	XOMED IONESTHETIZER(TM)	Feb 15, 1989	Unknown	Xomed, Inc.
K882554	MEDITRODE KIT	Dec 23, 1988	Unknown	Life-Tech Intl., Inc.
K871869	MODIFIED USE FOR MODEL 6110A IONTOPHORETIC APPLI.	Aug 11, 1987	Unknown	Life-Tech Intl., Inc.
K872040	PHORESOR II (TM), MODEL PM700	Aug 04, 1987	Substantially Equivalent	Motion Control, Inc.
K863166	MODEL 6110 IONTOPHORETIC APPLICATOR	Mar 04, 1987	Substantially Equivalent	Life-Tech Intl., Inc.
K853635	SUBDERM TM	Dec 20, 1985	Substantially Equivalent	General Medical Co.
K850508	LOGIKAL LONTOPHORESIS UNIT -ANESTHESIA INOTOPHORES	May 15, 1985	Substantially Equivalent	Kal Life Systems
K842483	SANTA BARBARA MEDCO-LANTOPHORETIC APPLIC	Aug 31, 1984	Substantially Equivalent	Santa Barbara Medco, Inc.
K831320	DRIONIC	Jul 19, 1983	Substantially Equivalent	General Medical Co.
K770717	IONTOPHORESIS SYSTEM MODULE, DM 500	Aug 15, 1977	Substantially Equivalent	Sorensen Research
K771130	DESENSITRON	Jul 15, 1977	Substantially Equivalent	Parker Laboratories, Inc.