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510(k) Data Aggregation

    K Number
    K160081
    Device Name
    TENS Electrodes
    Manufacturer
    CATHAY MANUFACTURING CORP.
    Date Cleared
    2016-10-19

    (278 days)

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

    CATHAY MANUFACTURING CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The proposed device is intended for use as the disposable, conductive adhesive interface between the patient's skin and the electrical stimulator to apply electrical stimulation current, and is intended to be used with marketed electrical stimulators. i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It's for OTC use.
    Device Description
    The proposed TENS Electrodes are non-sterile laminated, flexible structures composed of materials commonly used in this application: The electrodes are designed for single-patient application use. Because of the adhesive nature of the biocompatible hydrogel, no securing materials are required to secure the device to the patient's skin. The proposed device mainly consists of electrode pad and wire. The electrode pad is available in rectangular shape, round shape, and butterfly shape, etc.
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    K Number
    K130027
    Device Name
    DISPOSABLE NEUTRAL ELECTRODE GP202
    Manufacturer
    CATHAY MANUFACTURING CORP.
    Date Cleared
    2013-08-22

    (231 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    CATHAY MANUFACTURING CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This disposable neutral electrode for adult patients with conductive adhesive gel is used as neutral reference during electrosurgical procedures.
    Device Description
    The Disposable Neutral Electrode, is an accessory for high voltage high frequency electrosurgical devices, connect it to the body of the PATIENT and the HF SURGICAL EQUIPMENT, it can perform it function for provide a return path for the HIGH FREQUENCY current and unwanted burns are avoided. Construction --- The product consists of Electrode carrier and Clarity PET. It is packed in an al film bag. The electrode is composed of conductive gel, aluminum foil, sponge, anti-sticking film and connecting wire. Conductive gel is composed of high molecular monomer, glycerinum and water, which is a gel, can be conducted in high frequency and has voltage-sensitive by polymerization.
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