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510(k) Data Aggregation

    K Number
    K142159
    Device Name
    DISPOSABLE PRE-GELLED SURFACE ELECTRODE
    Manufacturer
    ROCHESTER ELECTRO MEDICAL, INC.
    Date Cleared
    2015-06-03

    (301 days)

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

    ROCHESTER ELECTRO MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Pre-gelled Surface Electrodes are intended for recording/stimulation and monitoring of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potential (EP) signals. The Rochester Electro-Medical Disposable Pre-gelled Surface Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of stimulating/recording of biopotential signals. Electrodes are applied in the study of biopotentials such as Electroencephalograph (EEG), surface Electromyography (EMG) and Evoked Potential signals (EP). Electrodes are non-invasive as they are applied to the patient's skin using a self-adhesive solid-gel surface. The electrodes are non-sterile and for single use only.
    Device Description
    A conductive solid gel electrode consisting of a conductive adhesive gel, a silver/silver chloride plated eyelet, an adhesive cloth substrate, label, lead wire with a 0.60" diameter touch-proof female socket per DIN 42802 and polystyrene release liner. These are available in various lead lengths, lead configurations, electrode styles/sizes, and wire colors.
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    K Number
    K080914
    Device Name
    ULTRASHARP CONCENTRIC NEEDLES
    Manufacturer
    ROCHESTER ELECTRO MEDICAL, INC.
    Date Cleared
    2008-07-15

    (105 days)

    Product Code
    IKT
    Regulation Number
    890.1385
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROCHESTER ELECTRO MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Recording muscle activity for Electromyography (EMG) applications. For single patient use only. Patient population: Adults.
    Device Description
    Bi-polar/multi-polar disposable concentric needles for recording muscle activity. The needles consist of a stainless steel hypodermic outer shell with a centered platinum/iridium inner recording core with a trocar sharpencd tip. An electrically insulated molded handle incorporates the contact points allowing electrical continuity through the connecting cable, which is sold separately.
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