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510(k) Data Aggregation

    K Number
    K163201
    Device Name
    KYMCO EQ10D Scooter
    Manufacturer
    KWANG YANG MOTOR CO., LTD.
    Date Cleared
    2017-03-16

    (121 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    KWANG YANG MOTOR CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
    Device Description
    The EQ10D scooter consists of an un-foldable platform which connects the two front wheels and two rear wheels, an adjustable tiller, two lead acid batteries with an off-board charger, a motor/electromagnetic brake assembly, a electric motor controller and a seat /backrest set. The patient uses the tiller handle/handlebar for steering and a thumb operated potentiometer throttle control lever located at the top of the tiller to engage and disengage the scooter motion in both the forward and reverse directions. When the throttle control lever is released, the electromagnetic brake will be actuated and the scooter is slow to stop. This scooter is designed for use on firm, even surfaces such as concrete, asphalt and indoor flooring.
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    K Number
    K130940
    Device Name
    KYMCO EQ20C SCOOTER
    Manufacturer
    KWANG YANG MOTOR CO., LTD.
    Date Cleared
    2013-10-07

    (186 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    KWANG YANG MOTOR CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is a motor drive, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disable or elderly person limited to a seated position.
    Device Description
    The EQ 20C scooter consists of an un-foldable platform which connects the two front wheels and two rear wheels, an adjustable tiller, two lead acid batteries with an on-board charger, a motor/electromagnetic brake assembly, a electric motor controller and a seat /backrest set. The patient uses the tiller handle/handlebar for steering and a thumb operated potentiometer throttle control lever located at the top of the tiller to engage and disengage the scooter motion in both the forward and reverse directions. When the throttle control lever is released, the electromagnetic brake will be actuated and the scooter is slow to stop.
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    K Number
    K082900
    Device Name
    KYMCO FORU, MODEL EQ10
    Manufacturer
    KWANG YANG MOTOR CO., LTD.
    Date Cleared
    2008-10-28

    (28 days)

    Product Code
    INI, 89I
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    KWANG YANG MOTOR CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide mobility to disabled or elderly persons limited to a seated position.
    Device Description
    The KYMCO ForU EQ10 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
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    K Number
    K082901
    Device Name
    KYMCO FORU, MODEL EQ20
    Manufacturer
    KWANG YANG MOTOR CO., LTD.
    Date Cleared
    2008-10-28

    (28 days)

    Product Code
    INI, 89I
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    KWANG YANG MOTOR CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KYMCO ForU EQ20 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position. To provide mobility to disabled or elderly persons limited to a seated position.
    Device Description
    The KYMCO ForU EQ20 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
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    K Number
    K081133
    Device Name
    KYMCO FORU, MODEL EQ40
    Manufacturer
    KWANG YANG MOTOR CO., LTD.
    Date Cleared
    2008-06-10

    (50 days)

    Product Code
    INI, 89I
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    KWANG YANG MOTOR CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide mobility to disabled or elderly persons limited to a seated position.
    Device Description
    The KYMCO ForU EQ40 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
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    K Number
    K072630
    Device Name
    FORU, MODEL EQ30
    Manufacturer
    KWANG YANG MOTOR CO., LTD.
    Date Cleared
    2007-10-03

    (15 days)

    Product Code
    INI, 89I
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    KWANG YANG MOTOR CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ForU EQ30 scooter is motor driven, indoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
    Device Description
    The ForU EQ30 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
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    K Number
    K072027
    Device Name
    FORU KV10HB
    Manufacturer
    KWANG YANG MOTOR CO., LTD.
    Date Cleared
    2007-08-20

    (27 days)

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

    KWANG YANG MOTOR CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ForU KV10HB powered wheelchair is 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 ForU 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. But the ForU KV10HB is kind oh a new class of lightweight powered wheelchair. By providing a powered wheelchair that breaks down into two manageable components (seat frame, body frame with motors and battery pack), a user can have a more practical alternative when traveling long distances by bus, train, etc.
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