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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    Merits Yoga Power Scooter, S542

    K Number: K142912 · Decision Jun 23, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    346
    Applicant Total
    19
    Review Days
    260

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    Basic Information

    Device Name
    Merits Yoga Power Scooter, S542
    K Number
    K142912
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    890.3800
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Merits Health Products Co., Ltd.
    Date Received
    October 6, 2014
    Decision Date
    June 23, 2015
    Product Code
    INI
    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
    INI Vehicle, Motorized 3-Wheeled

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