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510(k) Data Aggregation

    K Number
    K232025
    Device Name
    Hushd Pro Avera
    Manufacturer
    Good Sleep Co Pte Ltd.
    Date Cleared
    2024-05-09

    (307 days)

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

    Good Sleep Co Pte Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hushd Pro Avera device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
    Device Description
    The Hushd Pro Avera device series are a set of removable intraoral patient specific device used for treating snoring and mild to moderate obstructive sleep apnea. The device consists of number of custom made maxillary and mandibular splints fit over the upper and lower teeth. when interfaced together, functions as a mandibular repositioner holding the mandible forward during sleep thus preventing the togue and soft tissues of the throat from collapsing into the airway. The Hushd Pro Avera device series are patient-specific devices, consisting of one or more maxillary device(s) and one or more mandibular device(s) that mates together. The sequential devices are CAD/CAM designed and manufactured according to the requested mandibular advancements position prescribed by the dentist or physician to provide a selection of gentle advancements according to patient comfort and need. As such, prescribed advancements can be achieved by simply removing current maxillary or mandibular device and inserting the next maxillary or mandibular device in the advancements series. The maximum protrusion of the device is 10mm.The Hushd Pro Avera device does not have any adjustment mechanisms to modify or maintain the mandibular position such as pistons, straps or repositioning elastics.
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