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510(k) Data Aggregation

    K Number
    K180124
    Device Name
    ZQuiet
    Manufacturer
    Sleeping Well,LLC
    Date Cleared
    2018-06-12

    (147 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sleeping Well,LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ZQuiet is intended as an aid in the reduction of snoring for adults at least 18 years old.
    Device Description
    The ZQuiet is an oral appliance comprised of an upper and lower tray constructed in one piece and joined by a flexible hinge. The trays engage with the maxillary and mandibular dentition and the device maintains an anterior positioning of the mandible which widens the pharyngeal airway to prevent occlusion. The device is presented in varying protrusive sizes allowing the user to try different degrees of mandibular advancement to reduce snoring.
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