Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K192885
    Device Name
    C.T.M. Mobility Scooter HS-268
    Manufacturer
    Chien Ti Enterprise Co., Ltd.
    Date Cleared
    2019-12-09

    (60 days)

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

    Chien Ti Enterprise Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The C.T.M. Mobility Scooter HS-268 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person in age of 16 up to 85 year old.
    Device Description
    The C.T.M. Mobility Scooter HS-268 is an indoor/outdoor scooter that is powered by 25.2Vdc, 11000mAh, 277.2Wh (min) and 25.2Vdc, 11600mAh, 292.32Wh (typ) Lithium battery, equipped with four wheels, capacity of 253.5 lbs and a lightweight seat. It's a rear wheel drive scooter with theoretical driving ranges of 9.3 miles. 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 folded/unfolded and is provided with an off-board battery charger. The maximum speed is 5 mph.
    Ask a Question
    K Number
    K181344
    Device Name
    C.T.M Mobility Scooter
    Manufacturer
    CHIEN TI ENTERPRISE CO., LTD.
    Date Cleared
    2018-12-14

    (207 days)

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

    CHIEN TI ENTERPRISE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The C.T.M. Mobility Scooter HS-115 in an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
    Device Description
    The C.T.M. Mobility Scooter HS-115 is an indoor/outdoor scooter that is powered by two 12Ah lead-acid batteries, equipped with three wheels, capacity of 115 kilograms and a lightweight adjustable seat. It's a rear wheel drive scooter with theoretical driving ranges of 10 kilometer. 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 off-board battery charger. The maximum speed is 4 m.p.h.
    Ask a Question
    K Number
    K162952
    Device Name
    C.T.M. Mobility Scooter
    Manufacturer
    CHIEN TI ENTERPRISE CO., LTD.
    Date Cleared
    2017-05-03

    (191 days)

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

    CHIEN TI ENTERPRISE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The C.T.M. Mobility Scooter HS-328 in an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
    Device Description
    The C.T.M. Mobility Scooter HS-328 is an indoor/outdoor scooter that is powered by two 22Ah lead-acid batteries, equipped with four pneumatic wheels, capacity of 136 kilograms and a lightweight adjustable seat. It a rear wheel drive scooter with theoretical driving ranges of 17.5 kilometer. 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 off-board battery charger.
    Ask a Question

    Page 1 of 1