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510(k) Data Aggregation

    K Number
    K083044
    Device Name
    HUBANG, MODEL HBL13/HBG12-S
    Manufacturer
    SHANGHAI HUBANG MEDICAL APPLIANCES CO., LTD.
    Date Cleared
    2008-12-12

    (59 days)

    Product Code
    IOR, 89I
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANGHAI HUBANG MEDICAL APPLIANCES CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor or indoor.
    Device Description
    They consist of a rigid, mechanical, steel(HBG12-S)/aluminum(HBL13) frame and nylon upholstery back and seat. They have two 24" rear wheels and two 8" front casters for turning and maneuverability.
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