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510(k) Data Aggregation

    K Number
    K120302
    Device Name
    MECHANICAL WHEELCHAIR
    Date Cleared
    2012-07-06

    (156 days)

    Product Code
    Regulation Number
    890.3880
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVAF ANDALUCIA 2007, SL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Oceanic is a manual attendant-operated wheelchair intended to provide mobility to people with reduced-mobility problems.
    Device Description
    The Oceanic Wheelchair is a wheelchair suitable for use on different terrains and also in water. It can be used on surfaces like sand, snow, gravel, grass and in water. The user must be accompanied at all times, since it can not be driven by the person sat on it. This is a very long life product with the following components: Wheelchair, Foldable armrests, Foldable footrest, Starring/traction bar. The Oceanic is available in large (Oceanic) and small (Oceanic Baby) configurations which vary in length and also in the width and height of the Seat. The Oceanic Baby and Oceanic intended use is the same, but the Oceanic Baby has a maximum weight load of 50kg while the maximum weight load for the Oceanic is 100kg. All parts on our wheelchair are fabricated from aluminium and selected materials suitable for use in an aquatic environment. The chair can be submersed in water without any harmful effects. Users manual provides information on warnings, cautions, maintenance and operation instructions.
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