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

    HEARTWAY POWER MOBILITY SCOOTER

    K Number: K132855 · Decision Aug 29, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    346
    Applicant Total
    23
    Review Days
    351

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    Basic Information

    Device Name
    HEARTWAY POWER MOBILITY SCOOTER
    K Number
    K132855
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3800
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Heartway Medical Products Co., Ltd.
    Date Received
    September 12, 2013
    Decision Date
    August 29, 2014
    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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    Other Clearances by Heartway Medical Products Co., Ltd.

    K Number Device Name
    K220227 Auto Folding Scooter, S21F
    K151656 HEARTWAY Power Mobility Scooter
    K150998 HEARTWAY Power Mobility Scooter
    K150987 HEARTWAY Power Mobility Scooter, BRIO S19
    K142783 HEARTWAY Electrically Powered Wheelchair P27
    K142731 HEARTWAY Electrically Powered Wheelchairs
    K132856 HEARTWAY POWER WHEELCHAIR
    K101143 HEARTWAY POWER MOBILITY SCOOTER, S11
    K101142 HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S34
    K100327 HEARTWAY POWER CHAIR, P23
    Search all 23 clearances from Heartway Medical Products Co., Ltd. →