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510(k) Data Aggregation

    K Number
    K151693
    Device Name
    Dr-Ho's Foot Pad Electrode
    Manufacturer
    DRTV ASIA LTD
    Date Cleared
    2015-10-09

    (108 days)

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

    DRTV ASIA LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cutaneous Electrodes, "Dr-Ho's Foot Pad Electrodes", are intended to be used with legally marketed electrical stimulating devices such as transcutaneous electrical nerve stimulators or powered muscle stimulators. The cutaneous electrodes will deliver the stimulation signals generated by the stimulator to the feet which they are in contact with.
    Device Description
    The Dr-Ho's Foot Pad Electrode is a foot-shaped, flexible piece of conductive silicone rubber with a receptacle for a wire that connects the device with electrical stimulation devices such as transcutaneous electrical nerve stimulators (TENS) or powered muscle stimulators (PMS). To stimulate the bottom of the foot the patient simply connects the Foot Pad to a TENS unit, places the Foot Pad onto the floor and then places the foot onto the Foot Pad for stimulation with the TENS device. The Foot Pad Electrode has a female pin receptacle which accepts the lead wire from the stimulator. The entire Foot Pad Electrode is made up of conductive material to provide uniform current distribution when connected to a stimulator. The devices can be used dry or wet when in contact with the skin. The entire surface (approx. 35 in') of the Foot Pad Electrode is very conductive, having a resistance of less than 7 ohms per inch. This low resistance provides low current density with uniform current distribution.
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