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510(k) Data Aggregation

    K Number
    K173934
    Device Name
    Reza Band, Reflux Band
    Date Cleared
    2018-04-13

    (108 days)

    Product Code
    Regulation Number
    874.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    Somna Therapeutics, L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Reza Band and the Reflux Band are for people 18 years and older to reduce the symptoms of laryngopharyngeal reflux (LPR) disease by reducing the regurgitation of stomach contents from passing through the upper esophageal sphincter. The devices are worn by the user while sleeping.
    Device Description
    The Reza Band and Reflux Band are proposed for over the counter (OTC) use. The proposed devices are non-invasive and non-sterile worn by the user while sleeping. As with the predicate device (Reza Band), the proposed Reza Band and Reflux Band were designed as a treatment for LPR symptoms. The mode of operation of these devices is to provide slight external pressure, typically in a range of 20-30 mmHg, at the cricoid cartilage region. This external pressure increases the luminal pressure within the upper esophageal sphincter (UES). It has been shown that when the UES is subjected to the increased external pressure, it reduces stomach contents from coming up into the larynx, pharynx and lungs. The user positions the device around their neck. For the Reflux Band, the user uses an application (App) installed on an iOS or Android mobile device to fit the Reflux Band to the desired externally applied pressure. The electronics of the Reflux Band have been incorporated into its cushion (SmartCushion) so that the Reflux Band can interact with the App. For the Reza Band, the user utilizes the accessories External Manometer and Pressure Sensor to properly fit the device. A typical range is also 20-30mmHg of applied pressure. The components of the Reflux Band and Reflux Band are identical of a Cushion, Comfort Band, Frame, Comfort Dial and Clasp.
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