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510(k) Data Aggregation

    K Number
    K120922
    Device Name
    GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT
    Date Cleared
    2013-02-07

    (317 days)

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

    SELECTIVEMED COMPONENTS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction
    Device Description
    Guardian Dysphagia dual channel NMES is a lightweight battery powered dual channel neuromuscular stimulation device used for treating patients suffering from dysphagia. It is a prescription device administered to patients by or under the direction of a licensed healthcare provider in hospitals, post acute care facilities, nursing homes and outpatient clinics. The intended patient outcome is to regain control of muscles used to swallow food and drink liquids without aspirating. It is to be used with Guardian 150 electrode or other compatible electrodes cleared for the same indications for use, as well as lead wires.
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