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510(k) Data Aggregation

    K Number
    K112426
    Device Name
    XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES
    Manufacturer
    XIAN FRIENDSHIP MEDICAL ELECTRONICS CO., LTD.
    Date Cleared
    2012-04-02

    (223 days)

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

    XIAN FRIENDSHIP MEDICAL ELECTRONICS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Xian Friendship Disposable Nerve Stimulator Probes is used to perform localized stimulation of neural tissue and to locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery. Xian Friendship Disposable Nerve Stimulator Probes are sterile (EtO), single-patient-use device.
    Device Description
    Stimulator probes are used as the medium to deliver electrical stimulation to tissue during intraoperative neurological monitoring. The probes are available in three electrical configurations such as monopolar, bipolar and concentric forms according to the required application. The probes are supplied sterile and are for single use only. The probes are connected to an electrical stimulator using a flexible lead wire(s) and a "touch-proof' safety connector(s) on the distal end. Stimulator probes are used by the surgeon to locate and identify motor nerves and spinal nerve roots and to assess nerve function. Bipolar probes may also be used to record nerve action potentials directly from the nerve. The probes are designed with a plastic handle and stainless steel active electrode shaft insulated to the tip. The probe shaft may be bent to allow viewing access under a microscope. Concentric Probes is designed with an outer anode pole and center cathode pole separated by insulation. Tip diameter approx 1mm. Monopolar electrodes require a separate stimulator return electrode and the Monopolar probe is insulated to the tip with only a stimulating "ball" or "tip" exposed. Bipolar probe has a fully insulated probe shaft with two 1 mm exposed flush tips. The anode and cathode tips can spread up to 3 mm apart and will penetrate tissue for stimulation current to flow.
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    K Number
    K110289
    Device Name
    FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODE
    Manufacturer
    XIAN FRIENDSHIP MEDICAL ELECTRONICS CO., LTD.
    Date Cleared
    2011-08-30

    (210 days)

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

    XIAN FRIENDSHIP MEDICAL ELECTRONICS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable Pre-gelled Ag/AgCl Surface Electrodes are intended for recording/stimulation and monitoring of the Electromygraphy (EMG), Electroencephalograph(EEG) and Evoked Potential(EP) signals.
    Device Description
    Friendship's Pre-gelled Ag/AgCl Surface Electrodes are disposable (for "single Use Only"). Used to detect electrophysiological signals or provide electrical stimulation subcutaneously. The electrodes are the interface medium between the diagnostic or monitoring equipment and the patient. The surface electrodes is comprised of top woven layer, carbon layer, Ag/AgCl layer and hydrogel layer on one end electrically connected to lead wire and a touch-proof connector on the other end.
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