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EGJ — Device, Iontophoresis, Other Uses Class II

FDA Device Classification

Classification Details

Product Code
EGJ
Device Class
Class II
Regulation Number
890.5525
Submission Type
Review Panel
PM
Medical Specialty
Physical Medicine
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242041taiwan medical electronics coSTOPWET iontophoresis apparatus (SW01)April 1, 2025
K241267hidroxa medicalHidroxa SE30October 17, 2024
K232020top-rank health care coIontophoresis ElectrodesOctober 16, 2023
K192749dermadry laboratoriesDermadryFebruary 10, 2020
K191436saalmann medical gmbh and co. kgSaalioOctober 18, 2019
K170835hightech developmentElectro Antiperspirant, Electro Antiperspirant Sensitive, Electro AntiperspirantJune 15, 2018
K170291soterix medicalIontoDCMay 1, 2017
K150453acclarentTULA Iontophoresis System with EarsetMay 20, 2015
K133033hidrexHIDREX PSP1000April 8, 2015
K132832activatekACTIVAPATCH ET IONTOPHORESIS PATCHFebruary 13, 2014
K110636acclarentTULA IONTOPHORESIS SYSTEMJune 16, 2011
K083016microlab americasACTHYDERMJune 16, 2009
K091326activatekACTIVAPATCHMay 27, 2009
K080580axelgaard mfg. coCOMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MOJune 18, 2008
K073276acclarentIONTOPHORESIS SYSTEMMarch 5, 2008
K072946empiHYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEMNovember 16, 2007
K070427empiDUPEL TRANSPORT IONTOPHORESIS SYSTEMMay 14, 2007
K061849aa advanced technologyMESODERMApril 30, 2007
K062792erchonia medicalERCHONIA IOTO_240March 1, 2007
K063465iomedCHAMPION IONTOPHORETIC DRUG DELIVERY DEVICEFebruary 28, 2007