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510(k) Data Aggregation

    K Number
    K113463
    Device Name
    POWER WHEELCHAIR
    Manufacturer
    SUZHOU KD MEDICAL APPLIANCE CO., LTD.
    Date Cleared
    2012-04-06

    (136 days)

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

    SUZHOU KD MEDICAL APPLIANCE CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
    Device Description
    The PL001 powered wheelchair is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position. It consists of two foldable armrests, a seat belt, a backrest, a seat cushion, a foldable frame, two rear drive wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, two Li-ion batteries, an off-board battery charger, a control panel with connect cables and a electric motor controller. The device is powered by two 12 volt, 10 Ah, Li-ion batteries with 20 km(12.5 miles) range that can be recharged by an off-board battery charger that can be plugged into an AC outlet (110-220 V, 50-60 Hz) when the device is not in use. The patient can activate the joystick to move in the direction of the joystick is actuated. When the patient releases the joystick the device slows to stop and the brakes are automatically re-engaged.
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    K Number
    K100824
    Device Name
    MECHANICAL WHEELCHAIR, MODEL DS 202-S
    Manufacturer
    SUZHOU KD MEDICAL
    Date Cleared
    2010-05-25

    (62 days)

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

    SUZHOU KD MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DS 202-S manual wheelchair is intended use to provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor and indoor.
    Device Description
    DS 202-S manual wheelchair is intended use to provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor and indoor. It consists of a rigid, mechanical and foldable 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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