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510(k) Data Aggregation

    K Number
    K082634
    Device Name
    VERTIGONE BPPV GOGGLE
    Manufacturer
    VERTIGONE, INC.
    Date Cleared
    2009-04-07

    (209 days)

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

    VERTIGONE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VertiGONE goggle is indicated for the treatment of Benign Paroxysmal Positional Vertigo (BPPV). The VertiGONE goggle guides the practitioner to move the patient's head accurately through the Epley, or canalith repositioning maneuver.
    Device Description
    The VertiGONE BPPV Goggle is a head mounted medical device worn by the patient. The VertiGONE Goggle is designed as a non-intrusive device with nonsubstantial risk to the subjects. The subject device consists of a molded plastic goggle, an elastic strap to secure the goggle to the head, and a visual reference platform including two visual reference mechanisms. The VertiGONE Goggle provides a visual reference platform for the practitioner to guide the patient to accurately conduct the Epley, or canalith repositioning, maneuver. When using the device, the patient and/or the practitioner are each provided with visual references. Thus, the practitioner can help the patient to complete the Epley maneuver more accurately.
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