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510(k) Data Aggregation

    K Number
    K232888
    Device Name
    Disposable Laryngeal Electrodes
    Manufacturer
    Suzhou Haishen Medical Device Associates Co., Ltd
    Date Cleared
    2023-12-21

    (94 days)

    Product Code
    ETN
    Regulation Number
    874.1820
    Why did this record match?
    Applicant Name (Manufacturer) :

    Suzhou Haishen Medical Device Associates Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The disposable laryngeal electrodes are intended to be used as a disposable, self-adhesive electrodes attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures.
    Device Description
    The Disposable Laryngeal Electrodes are single used electrodes constructed from an medical-grade ink with a conductive polymer film covered by an insulating coating, a connector made of polypropylene and a cable assembly. The electrodes are designed to monitor the recurrent nerve during thyroid, anterior cervical, carotid endartecrectomy surgery and vagus nerve monitoring during brain surgery. The monitoring is performed with a surface electrode that is attached to an endotracheal tube placed on the vocal cord. A neutral adhesive electrode is placed on the patient's shoulder. Both adhesive electrodes are connected to a reusable recording cable and to the nerve monitor.
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    K Number
    K232581
    Device Name
    Medical Disposable Sterile Needle Electrode
    Manufacturer
    Suzhou Haishen Medical Device Associates Co., Ltd
    Date Cleared
    2023-12-04

    (101 days)

    Product Code
    GXZ
    Regulation Number
    882.1350
    Why did this record match?
    Applicant Name (Manufacturer) :

    Suzhou Haishen Medical Device Associates Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is intended for use with recording, monitoring equipment for the recording of bioelectrical signals, such as electromyograph (EMG). The electrodes are sterile and for single patient use only.
    Device Description
    Medical disposable sterile needle electrodes are sterile, single use products that penetrate the skin and directly contact the extracellular fluid during use, forming a good electrolyte interface. The pointed part of the needle electrode makes contact with the nerves, muscles, or other tissues under examination to collect and transmit the corresponding bioelectrical signals (myoelectric currents) to the electromyography (EMG) recorder. Needle electrodes are used in conjunction with EMG diagnostic instruments and serve as accessories to the EMG machine for detecting myoelectric potentials. Medical disposable sterile needle electrodes are invasive since they are positioned subcutaneously and are used under the supervision of a licensed physician. The subject device, available in configurations with and wires, which encompasses subdermal, monopolar, spiral, and concentric designs. The subject device's configurations of monopolar and concentric needles correspond to those without lead wires, while the configurations involving spiral and subdermal designs include lead wires.
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