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510(k) Data Aggregation

    K Number
    K223901
    Device Name
    ApneaRX Pro
    Manufacturer
    Apnea Sciences Coporation
    Date Cleared
    2023-09-01

    (247 days)

    Product Code
    LRK, REG
    Regulation Number
    872.5570
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    Applicant Name (Manufacturer) :

    Apnea Sciences Coporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ApneaRx Pro is intended for use on adult patients 18 years of age or older as an aid for the reduction of mild to moderate obstructive sleep apnea (OSA), and/or snoring.
    Device Description
    The ApneaRx Pro is an intraoral device that repositions the jaw anteriorly in order to increase the patient's pharyngeal space and minimizing air obstruction and turbulence. The device consists of two custom fabricated liners that fit separately over the upper and lower dental arches and engage in the posterior area of the mouth. The lower liner is snapfitted to a polycarbonate chassis that enables mandibular repositioning in 1 mm increments. The upper liner employs a hinged design to enable vertical movement of the jaws.
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