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    K Number
    DEN220025
    Device Name
    Phagenyx System
    Manufacturer
    Phagenesis Limited
    Date Cleared
    2022-09-16

    (150 days)

    Product Code
    QQGOOG
    Regulation Number
    874.5950
    Why did this record match?
    Product Code :

    QQG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Phagenyx System is a neurostimulation device delivering electrical stimulation to the oropharynx, to be used in addition to standard dysphagia care, as an aid to improve swallowing in patients with severe dysphagia post stroke.
    Device Description
    The Phagenyx System comprises; a sterile single-patient use catheter (PNX-1000) and a Base Station (EPSB3). The catheter is a two-part fine bore that is introduced nasally and extends down as far as the patients' stomach. It incorporates two bipolar ring electrodes on its outer surface to deliver the electrical stimulation. It also incorporates a feeding tube to facilitate delivery of nutrition or hydration. The Base Station has a touch screen user interface that facilitates the optimization of stimulation levels for treatment and stores patient and treatment information.
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