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510(k) Data Aggregation

    K Number
    K011752
    Device Name
    GOVAN+ WHEELCHAIR AND DOCKING ACCESSORY
    Manufacturer
    Date Cleared
    2001-06-28

    (22 days)

    Product Code
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACCUFAST, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Therapeutic effect: - Provision of out-of-bed seating for disabled persons. - Transportation of disabled persons from one location to another in a room or in a building or outdoors. - Transportation of disabled persons in the device in motor vehicles. Medical conditions for which the device is indicated: - Post-operative weakness or debility. - Age-related weakness or debility. - Paralysis due to stroke, tumour, etc. - Impairment of function due to MS, ALS, Polio. - Impairment from physical trauma. - Impairment from accidents at birth.
    Device Description
    Designed to remedy perceived shortfalls in the design of standard wheelchairs, particularly in the category of user safety, the GOVAN+ device's distinctive appearance confirms that it is not meant to be a duplicate of the predicate device.
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