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510(k) Data Aggregation

    K Number
    K023993
    Manufacturer
    Date Cleared
    2002-12-27

    (24 days)

    Product Code
    Regulation Number
    890.3850
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    GALAXY SERIES WHEELCHAIR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Galaxy Series Wheelchair provides enhanced mobility to physically challenged Persons limited to a sitting position.

    Device Description

    The Galaxy Series Wheelchair is manually operated mechanical wheelchair. It is designed to be light in weight with folding frame. The range of sizes and configurations are available to accommodate the needs of each user. The wheelchair is suitable to provide mobility to user for both indoors and outdoors with firm surface that is free of climbing obstacles.

    The Galaxy Series Wheelchair consists of typical components found on most manual wheelchair. The wheelchair consists of metal frame constructed of round steel tubing that is welded, seat and back upholsteries, removable footrests, front casters and rear wheels. The upholstery fabric meets the California Technical Bulletin CAL 117 Standard for flame retardancy.

    The users manual of Galaxy Series Wheelchair provides information on warnings, cautions and operation instruction of the wheelchair.

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