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510(k) Data Aggregation

    K Number
    K113375
    Device Name
    ESWALLOW USA ELECTRODE,ESWALLOW USA LEADWIRE
    Manufacturer
    Date Cleared
    2013-01-25

    (436 days)

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

    ESWALLOW USA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For muscle reeducation by application of external stimulation to the muscles necessary for pharyngeal contraction.
    Device Description
    The devices are single patient, multiple-use [up to three times] cutaneous electrodes for the application of electrical stimulation. The lead wire is attached to the electrode and is designed to be connected to a transcutaneous external muscle stimulator. The cutaneous electrodes are available in two sizes; one for adult patients and one for youth patients. Both sizes are composed of identical materials. The cutaneous electrodes and lead wire do not contain active electronics, software or firmware. The lead wire connects to the cutaneous electrotherapy device. The cutaneous electrodes are composed of materials commonly used in this application: polyethylene, medical grade adhesives, 'spunlace' non-woven, carbon film, silver, polyester, and hydrogel.
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    K Number
    K092202
    Device Name
    ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT
    Manufacturer
    Date Cleared
    2011-02-10

    (568 days)

    Product Code
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    ESWALLOW USA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is intended for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.
    Device Description
    This device is a dual channel battery operated electrical stimulator for use with skin surface electrodes. The output current in each channel can be adjusted from 0-25 ma in 1 ma increments. The pulse repetition rate is fixed at 80 Hz. The output waveform is bipolar symmetrical constant current.
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