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510(k) Data Aggregation

    K Number
    K071973
    Device Name
    EPLEY OMNIAX
    Manufacturer
    VESTICON
    Date Cleared
    2008-06-20

    (339 days)

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

    VESTICON

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Epley Omniax is intended to assist in the diagnosis and treatment of balance disorders and vertigo, including benign paroxysmal positional vertigo.
    Device Description
    The Epley Omniax is a multi-axial positional chair that includes the chair unit and an operator's pedestal. The chair unit includes the chair itself attached to a frame assembly. seat belts and other restraints, and videonystagmography goggles attached to a computer. The operator's pedestal includes the power distribution system, isolation transformer, and computer with monitor, keyboard, and mouse. The two computers communicate wirelessly to transmit and record the chair movements and the eye movements. The device has a number of safety features, such as emergency stop buttons, override buttons, pinch guards, and manual crank in case of power failure. The patient is strapped into the Omniax, dons goggles with a camera attached, and the operator selects a series of moves utilizing one or both of the axes. The position of the patient in relation to gravity and any eye movements are shown on the operator's computer and recorded for future viewing. Review of these recordings allows the operator to assess conditions and select appropriate treatment.
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