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510(k) Data Aggregation

    K Number
    K082274
    Device Name
    HAIDA MODEL HD11 MANUAL WHEELCHAIR
    Manufacturer
    JIANGYIN EAST CHINA MEDICAL TECHNOLOGY CO., LTD.
    Date Cleared
    2008-08-19

    (8 days)

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

    JIANGYIN EAST CHINA MEDICAL TECHNOLOGY 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
    It consists of a rigid, mechanical, steel frame and nylon upholstery back and seat. It has two 24" rear wheels and two 8" front casters for turning and maneuverability.
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    K Number
    K082288
    Device Name
    HAIDA HD21
    Manufacturer
    JIANGYIN EAST CHINA MEDICAL TECHNOLOGY CO., LTD.
    Date Cleared
    2008-08-19

    (8 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    JIANGYIN EAST CHINA MEDICAL TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HAIDA HD21 powered wheelchair is intended for an indoor/outdoor power wheelchair that provides transportation for disabled or elderly persons limited to a seated position. It is a motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
    Device Description
    The HAIDA HD21 powered wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The design of this wheelchair is basically similar to other powered wheelchairs that are already on the market.
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