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

    WU'S 3-WHEELED NEO SCOOTER, WT-M3

    K Number: K014119 · Decision Jul 25, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    327
    Applicant Total
    21
    Review Days
    220

    Basic Information

    Device Name
    WU'S 3-WHEELED NEO SCOOTER, WT-M3
    K Number
    K014119
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3800
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    WU'S TECH CO., LTD.
    Date Received
    December 17, 2001
    Decision Date
    July 25, 2002
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (INI), ordered by most recent decision date.

    Mobility Scooter (JT10)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Magnesium alloy scooter (RS100)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Mobility Scooter (Model X-01, X-02)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Powered Mobility Scooter

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Mobility Scooter (MS160A)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Mobility Scooter (S-01); Mobility Scooter (S-02)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine
    View all

    Other Clearances by WU'S TECH CO., LTD.

    K Number Device Name
    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
    K070655 WU'S POWERED WHEELCHAIR, MAMBO 36
    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
    K040968 WU'S 4-WHEELED NEO SCOOTER, MODEL WT-T4D
    Search all 21 clearances from WU'S TECH CO., LTD. →