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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: EGJ FDA class 2

    Device, Iontophoresis, Other Uses

    Physical Medicine

    View full classification →

    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.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    STOPWET iontophoresis apparatus (SW01)
    Hidroxa SE30
    Iontophoresis Electrodes
    Dermadry
    Saalio
    Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE
    IontoDC
    TULA Iontophoresis System with Earset
    HIDREX PSP1000
    ACTIVAPATCH ET IONTOPHORESIS PATCH
    TULA IONTOPHORESIS SYSTEM
    ACTHYDERM
    ACTIVAPATCH
    COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D
    IONTOPHORESIS SYSTEM
    HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM
    DUPEL TRANSPORT IONTOPHORESIS SYSTEM
    MESODERM
    ERCHONIA IOTO_240
    CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE
    TRIVARION BUFFERED IONTOPHORESIS ELECTRODE SYSTEM
    DYNATRON ION IONTOPHORESIS ELECTRODE
    COMFORT/IO IONTOPHORESIS ELECTRODES
    MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE
    NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE
    DYNATRON IBOX IONTOPHORESIS DEVICE
    TRANSDERM IONTO SYSTEM, MK 2
    MEDICAL ADHESIVEONLINE, LLC. IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 23001, 23002, 23003, 23004, AND 24001
    NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401, 201-402, 201-403 AND 201-405
    TRSANSDERM IONTO SYSTEM
    E-STRIP
    SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7
    MINIPHYSIONIZER 2.0 AND ELECTRODES
    EMPI ACTION PATCH IONTOPHORESIS SYSTEM
    MEDION 6000
    IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE)
    IO-DRIVE
    IONTOPATCH
    DUPEL IONTOPHORESIS SYSTEM
    PHORESOR II,MODEL PM900
    DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE
    DUPEL II BUFFERED IONTOPHORESIS ELECTRODES
    MD-1A GALVANIC UNIT
    IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II
    DYNAPHOR(TM) TWO
    RH-801/GS MODEL TRANSQ(R)1
    RH-806/GS MODEL TRANSQ(R)2
    PHORESOR II AUTO, MODEL PM800 MODIFICATION
    MICROPHOR
    DUPEL IONTOPHORESIS DEVICE

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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