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510(k) Data Aggregation

    K Number
    K221199
    Device Name
    Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode)
    Manufacturer
    Green Island International TCM Group Limited
    Date Cleared
    2023-12-19

    (602 days)

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

    Green Island International TCM Group Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Conductive Silicone Electrode is intended to be used with legally marketed electrical stimulation devices such as transcutaneous electrical nerve stimulators. Conductive Silicone Electrode will deliver the stimulation signals generated by the stimulator to the surface where it is in contact with.
    Device Description
    Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode)
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