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510(k) Data Aggregation

    K Number
    K240108
    Device Name
    Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX-WRIST01; GMX-ELBOW01; GMX-LEG01, GMX-ANKLE01, GMX-KNEE01; GMX-FOOT PAD01; GMX-GLOVES01; SHOULDER01; GMX-NCK01)
    Manufacturer
    Gymmax Technology Shenzhen Co., Ltd.
    Date Cleared
    2024-06-10

    (146 days)

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

    Gymmax Technology Shenzhen Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wrap Accessory Electrodes are intended to be used with legally marketed electrical stimulating devices such as transcutaneous electrical nerve stimulators or powered muscle stimulators. The wrap accessory electrodes will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. The wrap accessory electrodes, made up of conductive silicone rubber, can be used for the stimulation on the body areas such as abdomen, neck, shoulder, elbow, leg, Hand, wrist, ankle, knee and foot.
    Device Description
    Wrap Accessory Electrodes with GMX-ABSBELT01、GMX-ABSBELT02、GMX-WRIST01、 GMX-ELBOW01、GMX-LEG 01、GMX-ANKLE01、GMX-KNEE01、GMX-FOOT PAD 01、 GMX-GLOVES 01、SHOULDER01、GMX-NCK01, are intended to be used with legally Marketed transcutaneous electrical nerve stimulators or powered muscle stimulators which could be used in place of traditional cutaneous electrode patches. The different series of model means different placement of the Wrap Accessory Electrodes. The wrap accessory electrodes will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. The wrap accessory electrodes, made up of conductive silicone rubber, can be used for the stimulation on the body areas such as abdomen, neck, shoulder, elbow, leg, Hand, wrist, ankle, knee and foot.
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