BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Electrically Powered Wheelchair, Joy Rider

    K Number: K220156 · Decision Oct 7, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    6
    Review Days
    261

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    Basic Information

    Device Name
    Electrically Powered Wheelchair, Joy Rider
    K Number
    K220156
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tung Keng Enterprise Co., Ltd.
    Date Received
    January 19, 2022
    Decision Date
    October 7, 2022
    Product Code
    ITI
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ITI Wheelchair, Powered

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    Other Clearances by Tung Keng Enterprise Co., Ltd.

    K Number Device Name
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    K033220 BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S280
    K033239 BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500
    K033219 BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S600
    K033241 BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S320