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510(k) Data Aggregation

    K Number
    K112319
    Device Name
    ELECTRO-CAP SYSTEM
    Manufacturer
    ELECTRO-CAP INTL., INC.
    Date Cleared
    2012-01-27

    (169 days)

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

    ELECTRO-CAP INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Electro-Cap System is intended for use in routine clinical and research settings where rapid placement of a number of EEG electrodes is desired.
    Device Description
    The Electro-Cap System is an EEG electrode positioning system used to quickly place the standard 20 EEG electrodes and also a large number of electrodes in a uniform and consistent manner on the head and body in order to transmit electrophysiological signals from an individual to data collection devices. The Electro-Cap is made from a spandex type material with recessed electrodes in plastic mounts attached to the cap. The standard cap covers the entire scalp and is held in place with chin straps, or with cap straps attached to a body harness. The Surgical Cap material is cut slightly different to allow the cap to fit securely over the ears to hold it in place. The spandex type material holds the electrodes securely in position during an EEG recording. Wires are attached to each electrode and exit the cap to form a cable, which is used to connect the cap to the EEG equipment, either through an adapter cable, or in some instances, directly to the equipment with the connector on the cap. The electrical activity of the brain is transferred through the Electro-Gel to the recessed electrode and then to the EEG or computer equipment for evaluation.
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    K Number
    K111717
    Device Name
    ELECTRO-GEL
    Manufacturer
    ELECTRO-CAP INTL., INC.
    Date Cleared
    2012-01-05

    (199 days)

    Product Code
    GYB
    Regulation Number
    882.1275
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELECTRO-CAP INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Electro-Gel is intended for use in clinical and research EEG/EP recordings from humans. It is used with external electrodes as the conductor between the scalp and the (recessed) electrodes. It also reduces impedance (resistance to alternating current) between the electrode surface and the skin.
    Device Description
    Electro-Gel is the conductor between the scalp and the (recessed) electrodes. It also reduces impedance (resistance to alternating current) between the electrode surface and the skin. The electrical activity of the brain is transferred to the electrode and then to the EEG or computer equipment. Electro-Gel is for use with external electrodes only. Electro-Gel is an off white color, water-miscible conductive gel consisting of Sodium Chloride as the conductor combined with thickening agents, emulsifiers, humectants and preservatives all in an aqueous solvent. The pH range is 4.5 to 6.0 pH, Viscosity range is 575 to 615 cp. and Impedance 0.5K/Ohms or less. Direct contact with the Electro-Gel should not exceed 8 hours in any single recording session. The Electro-Gel is available in the following jar sizes: 16 ounce and 128 ounce. Shelf life is 1 year if stored properly, i.e. kept with containers tightly closed and at room temperature.
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