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510(k) Data Aggregation

    K Number
    K080276
    Device Name
    SELF-ADHESIVE ELECTRODES
    Manufacturer
    CATHAY HEALTHCARE EQUIPMENT MANUFACTURING, INC
    Date Cleared
    2008-08-04

    (182 days)

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

    CATHAY HEALTHCARE EQUIPMENT MANUFACTURING, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The electrotherapy electrodes are intended to be used to apply electrical stimulation current to the patient's skin or record physiological signals
    Device Description
    This type of electrode features a high density carbon mesh that evenly distributes current throughout the electrode surface. It connects to a TENS device through single or twin lead wire. Various standard sizes can be chosen. Any custom design can also be manufactured.
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