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

    WU'S POWERED WHEELCHAIR, MAMBO 36

    K Number: K070655 · Decision Apr 2, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    23
    Review Days
    24

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    Basic Information

    Device Name
    WU'S POWERED WHEELCHAIR, MAMBO 36
    K Number
    K070655
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wu'S Tech Co., Ltd.
    Date Received
    March 9, 2007
    Decision Date
    April 2, 2007
    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 Wu'S Tech Co., Ltd.

    K Number Device Name
    K192308 Wu's Electrical Scooter
    K181163 Wu's Powered Wheelchair
    K091212 WU'S 3 WHEELED ELECTRICAL SCOOTER, WT-T3H
    K082963 WU'S 4-WHEELED NEO SCOOTER, WT-M3A
    K072337 WU'S 4-WHEELED NEO SCOOTER, MODEL WT-M4A
    K062790 WU'S 3-WHEELED NEO SCOOTER, MODEL WT-T3E
    K052559 WU'S POWERED WHEELCHAIR, MAMBO 2
    K050042 WU'S 4-WHEELED NEO SCOOTER, WT-XL4
    K050010 WU'S POWERED WHEELCHAIR, MAMBO 36X
    K050011 WU'S POWERED WHEELCHAIR, MAMBO F 120
    Search all 23 clearances from Wu'S Tech Co., Ltd. →