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510(k) Data Aggregation

    K Number
    K222127
    Device Name
    Soft Palate Elevator
    Date Cleared
    2022-10-24

    (98 days)

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

    The TMJ Clinic, PC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TREATMENT OF SNORING
    Device Description
    The soft palate elevator consists of an upper base appliance with a palatal plate from which a thin flat metal arm extends posterior end to terminate in a silicone rubber bulb that raises the center of the soft palate in order to "tent" that flexible structure to draw its distal end upward and forward away from the pharyngeal wall and to tighten the pharyngeal wall. The front end of the arm contains undercut tabs that extend out to the sides to lock into the acrylic in the palatal plate of the base appliance, and the back end of the arm contains features engineered to retain the rubber bulb. The arm is strong enough to elevate the middle of the soft palate about ¼'' when it is at rest during sleep and also flexible enough to move up and down with the natural action of the soft palate during swallowing when breathing stops anyway.
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