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

    Y.E.S POWERED WHEELCHAIR. T180

    K Number: K032512 · Decision Nov 12, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    Y.E.S POWERED WHEELCHAIR. T180
    K Number
    K032512
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Yeou Eir Shuen Machinery Co., Ltd.
    Date Received
    August 14, 2003
    Decision Date
    November 12, 2003
    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 Yeou Eir Shuen Machinery Co., Ltd.

    K Number Device Name
    K032669 Y.E.S. POWERED WHEELCHAIR, MODEL T200