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

    FX 222-02 POWERED WHEELCHAIR

    K Number: K110036 · Decision Mar 28, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    1
    Review Days
    82

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    Basic Information

    Device Name
    FX 222-02 POWERED WHEELCHAIR
    K Number
    K110036
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lanzhou Wanli Aviation Electromechanical, Inc.
    Date Received
    January 5, 2011
    Decision Date
    March 28, 2011
    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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