Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K173808
    Device Name
    Voutia™
    Date Cleared
    2018-07-27

    (224 days)

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

    Jeffrey Ward Cash, DDS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Voutia™ system is indicated to provide relief of dry mouth by coating, and lubricating oral structures thereby relieving the symptoms of xerostomia (dry mouth).
    Device Description
    Voutia™ is a non-sterile, single person use device for the treatment of xerostomia, consisting of a circuit board controlled pump, a fluid reservoir bottle, and tubing extension that goes from the pump, over a person's ear and transitions to a smaller tube that terminates in the user's oral cavity. The Voutia™ system delivers potable water to the mouth at nine (9) preprogrammed user selectable rates over a defined time, allowing stationary or portable hands free use.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1