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510(k) Data Aggregation

    K Number
    K220156
    Device Name
    Electrically Powered Wheelchair, Joy Rider
    Manufacturer
    Tung Keng Enterprise Co., Ltd.
    Date Cleared
    2022-10-07

    (261 days)

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

    Tung Keng Enterprise Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is a motor-driven, and indoor transportation vehicle with the intended use to provide mobility to a disabled or an elderly person limited to a seated position.
    Device Description
    The TUNG KENG Electrically Powered Wheelchair, Joy Rider, is suitable for indoor uses. It is characterized by high portability in comfortable travel, small storage and convenient delivery in daily life. As folding of Joy Rider only takes just a few seconds, so this model increases opportunities for travel and provides small storage. To use Joy Rider makes your travel in any place and at any moment! It is an individual transportation vehicle for disabled and elderly people that experience difficulties in walking. The Joy Rider comes as preassembled, designed to be lightweight, easily maneuvered, highly portable, and most importantly, safe and comfortable. It is driven by two brushless DC motors, and contains two foldable armrests, a seat belt, a backrest, a seat cushion and small with light texture, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, one Lithium-ion battery, an off-board battery charger, a control panel, and an electrical controller. The device is powered by one 24 VDC/ 10.5 Ah Lithium-ion battery with 9.3 miles cruising range that can be recharged by an off-board battery charger, rated at input: 100-240 VAC / 50-60 Hz, and output: 24 VDC/ 2 A, that can be plugged into an AC outlet, when the device is not in use. Its overall dimensions are 33.6' x 22.6' x 35.8" (855 x 580 x 910 mm). The user can activate the joystick to move in the direction of the joystick is actuated. When the user releases the joystick, the device slows to stop and the brakes are automatically re-engaged. The maximum weight capacity of Joy Rider is 264 lbs. (120 kg) and its maximum speed is 3.75 mph (6 km/h).
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    K Number
    K033220
    Device Name
    BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S280
    Manufacturer
    TUNG KENG ENTERPRISE CO., LTD.
    Date Cleared
    2003-12-18

    (76 days)

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

    TUNG KENG ENTERPRISE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
    Device Description
    The Be-Mobile 4-Wheeled Electric Scooter DK S280 is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
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    K Number
    K033240
    Device Name
    BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S200
    Manufacturer
    TUNG KENG ENTERPRISE CO., LTD.
    Date Cleared
    2003-12-18

    (73 days)

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

    TUNG KENG ENTERPRISE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
    Device Description
    The Be-Mobile 3-wheeled Electric Scooter DK S200 is an indoor / outdoor electric scooter that is battery operated. It has a base with 3-wheeled with a seat. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
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    K Number
    K033219
    Device Name
    BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S600
    Manufacturer
    TUNG KENG ENTERPRISE CO., LTD.
    Date Cleared
    2003-11-12

    (40 days)

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

    TUNG KENG ENTERPRISE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
    Device Description
    The Be-Mobile 4-Wheeled Electric Scooter DK S600 is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
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    K Number
    K033239
    Device Name
    BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500
    Manufacturer
    TUNG KENG ENTERPRISE CO., LTD.
    Date Cleared
    2003-11-12

    (37 days)

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

    TUNG KENG ENTERPRISE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
    Device Description
    The Be-Mobile 4-Wheeled Electric Scooter DK S500 is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
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    K Number
    K033241
    Device Name
    BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S320
    Manufacturer
    TUNG KENG ENTERPRISE CO., LTD.
    Date Cleared
    2003-11-10

    (35 days)

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

    TUNG KENG ENTERPRISE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
    Device Description
    The Be-Mobile 3-wheeled Electric Scooter DK S320 is an indoor / outdoor electric scooter that is battery operated. It has a base with 3-wheeled with a seat. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an enboard battery charger.
    Ask a Question

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