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510(k) Data Aggregation

    K Number
    K132422
    Device Name
    PALS PLATINUM NEUROSTIMULATION ELECTRODES
    Manufacturer
    AXELGAARD MFG. CO., LTD.
    Date Cleared
    2014-02-13

    (192 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    AXELGAARD MFG. CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PALS® reusable, self-adhering, over-the-counter Neurostimulation Electrodes are indicated for use with transcutaneous electrical stimulation devices. Some common types of transcutaneous stimulation devices include, but are not limited to, transepithelial nerve stimulation (TENS) and electrical muscle stimulation (EMS) devices. Transcutaneous Neurostimulation Electrodes are passive devices serving as an interface between a user's skin and a neurostimulation device.
    Device Description
    The Axelgaard PALS® Neurostimulation reusable self-adhering electrode is used as a transcutaneous electrical nerve stimulation electrode in conjunction with an electrical stimulator for TENS or EMS. The device functions as a passive device by carrying an electrical signal from a neurostimulation device through the device cable and electrode lead wire to the user skin. It is composed of a cover, connector lead wire, strelchable conductive fabric, conductive hydrogel, and an electrode carrier distribution is delivered via a connector lead wire stripped to an additional length.
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    K Number
    K130987
    Device Name
    VALUTRODE NEUROSTIMLATION ELECTRODES
    Manufacturer
    AXELGAARD MFG. CO., LTD.
    Date Cleared
    2013-07-17

    (99 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    AXELGAARD MFG. CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ValuTrode® reusable, self-adhering, over-the-counter Neurostimulation Electrodes are indicated for use with transcutaneous electrical stimulation devices. Some common types of transcutaneous stimulation devices include, but are not limited to, transepithelial nerve stimulation (TENS) and electrical muscle stimulation (EMS) devices. Transcutaneous Neurostimulation Electrodes are passive devices serving as an interface between a user's skin and a neurostimulation device.
    Device Description
    The ValuTrode® reusable self-adhering electrode is used as a transcutaneous electrical nerve stimulation electrode in conjunction with an electrical stimulator for TENS or EMS. The device functions as a passive device by carrying an electrical signal from a neurostimulation device through the device cable and electrode lead wire to the user skin. It is composed of a cover, connector lead wire, or snap, conductive carbon film, conductive hydrogel, and an electrode carrier liner. Proper current distribution is delivered via a connector lead wire stripped to an additional length, or use of a printed silver pattern.
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    K Number
    K080580
    Device Name
    COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D
    Manufacturer
    AXELGAARD MFG. CO., LTD.
    Date Cleared
    2008-06-18

    (107 days)

    Product Code
    EGJ
    Regulation Number
    890.5525
    Why did this record match?
    Applicant Name (Manufacturer) :

    AXELGAARD MFG. CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Iontophoresis is indicated by clinicians for the administration of soluble salts or other drugs into the body for medical purposes and can be used as an alternative to hypodermic injection.
    Device Description
    Comfort Iontophoresis Electrodes (Buffered Iontophoresis Electrode Treatment Kit) consist of an active drug delivery electrode and a passive return electrodes are designed for one use on a single patient for the local administration of ionic drug solutions into the body for medical purposes. There are four sizes and for the roundinen a releaser of roles to accommodate placement on various locations on the body. The size of the return electrode is the same for all drug delivery electrode sizes as the maximum delivery of 80 milliamp-minutes is the same regardless of size. Comfort Iontophoresis Electrodes (Buffered Iontophoresis Electrode Treatment Kit) have technological characteristics equivalent to those of the predicate devices, including comparable design, materials, multiple shapes and sizes of active drug delivery electrodes, and equivalent packaging and abeling.
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    K Number
    K013532
    Device Name
    ULTRASTIM KIT
    Manufacturer
    AXELGAARD MFG. CO., LTD.
    Date Cleared
    2002-08-22

    (309 days)

    Product Code
    GZJ, GXY, IQE
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    AXELGAARD MFG. CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UltraStim Kit is intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
    Device Description
    Not Found
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    K Number
    K000947
    Device Name
    ULTRASTIM ELECTRODE, MODEL US4040
    Manufacturer
    AXELGAARD MFG. CO., LTD.
    Date Cleared
    2000-06-16

    (85 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    AXELGAARD MFG. CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000206
    Device Name
    PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200
    Manufacturer
    AXELGAARD MFG. CO., LTD.
    Date Cleared
    2000-04-13

    (83 days)

    Product Code
    DRX
    Regulation Number
    870.2360
    Why did this record match?
    Applicant Name (Manufacturer) :

    AXELGAARD MFG. CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K983741
    Device Name
    EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020
    Manufacturer
    AXELGAARD MFG. CO., LTD.
    Date Cleared
    1998-12-18

    (57 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    AXELGAARD MFG. CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Everlast Neurostimulation Electrodes are intended for use with transcutaneous neurostimulation devices.
    Device Description
    Not Found
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    K Number
    K970426
    Device Name
    VALUETRODE
    Manufacturer
    AXELGAARD MFG. CO., LTD.
    Date Cleared
    1997-05-09

    (94 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    AXELGAARD MFG. CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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