BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇪🇸 Spain

    MECHANICAL WHEELCHAIR

    K Number: K120302 · Decision Jul 6, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    23
    Applicant Total
    1
    Review Days
    156

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    Basic Information

    Device Name
    MECHANICAL WHEELCHAIR
    K Number
    K120302
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3880
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Novaf Andalucia 2007, SL
    Date Received
    February 1, 2012
    Decision Date
    July 6, 2012
    Product Code
    IQC
    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
    IQC Wheelchair, Special Grade

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