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510(k) Data Aggregation

    K Number
    K142470
    Device Name
    E-Shield Multi-paried Subdermal Needle Electrodes
    Manufacturer
    NEUROINVENT INC.
    Date Cleared
    2014-11-05

    (63 days)

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

    NEUROINVENT INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    E-Shield Multi-paired Subdermal Needle Electrodes are intended for use with recording and monitoring equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephagraph (EEG) and Nerve potential signals. The electrodes are sterile and for single patient use only.
    Device Description
    E-Shield Multi-paired Subdermal Needle Electrodes are single use, disposable, monopolar, non-pyrogenic and sterilized stainless steel subdermal needle electrodes. Electrodes are applied in the study of biopotentials such as electroencephalograph (EEG), electromyography (EMG). Electrodes are invasive as they are placed subcutaneously or in contact with nerve or muscle tissue. The subdermal needle electrodes can be used to record variety of types of neurological and neurophysiological evoked potentials, including but not limited to electroencephalogram (EEG), electromyogram (EMG) in hospital and clinical setting. It is highly recommended to be used of intra-operative neuromonitoring (IOM). The electrodes consist of a stainless steel needle with a lead wire attached and the lead wires terminate in a safety connector. The electrodes are used under the supervision of a physician. There are three specifications for E-Shield Multi-paired Subdermal Needle Electrodes, 7mm, 13mm and 19mm. The sterilized PET box contains 2 sets of 5-paired, 2 sets of 4-paired or 1 set of single subdermal needle electrodes and a safety shield attached to each set. The safety shield is used to cover the needle sharps and the multi-paired lead wires are designed in group for easy organizing. Grouped wire cable can be separated into multi-paired lead wires to reach different recording sites of a patient over desired length. For instance, it can be used for the recording in one limb muscle groups.
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    K Number
    K140200
    Device Name
    E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES
    Manufacturer
    NEUROINVENT INC.
    Date Cleared
    2014-07-18

    (172 days)

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

    NEUROINVENT INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    E-Shield Multi-paired Subdermal Needle Electrodes are intended for use with recording and monitoring equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephagraph (EEG) and Nerve potential signals. The electrodes are sterile and for single patient use only.
    Device Description
    E-Shield Multi-paired Subdermal Needle Electrodes are single use, disposable, monopolar, non-pyrogenic and sterilized stainless steel subdermal needle electrodes. Electrodes are applied in the study of biopotentials such as electroencephalograph (EEG), electromyography (EMG). Electrodes are invasive as they are placed subcutaneously or in contact with nerve or muscle tissue. The subdermal needle electrodes can be used to record variety of types of neurological and neurophysiological evoked potentials, including but not limited to electroencephalogram (EEG), electromyogram (EMG) in hospital and clinical setting. It is highly recommended to be used of intra-operative neuromonitoring (IOM). The electrodes consist of a stainless steel needle with a lead wire attached and the lead wires terminate in a safety connector. The electrodes are used under the supervision of a physician. Each sterilized PET box contains 2 sets of 5-paired subdermal needle electrodes and a safety shield attached to each set. The safety shield is used to cover the needle sharps and the multi-paired lead wires are designed in group for easy organizing. Grouped wire cable can be separated into 5 paired lead wires to reach different recording sites of a patient over desired length. For instance, it can be used for the recording in one limb muscle groups.
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