BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PEDIATRIC FOLDING WHEELCHAIR

    K Number: K130644 · Decision Oct 16, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    219

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    Basic Information

    Device Name
    PEDIATRIC FOLDING WHEELCHAIR
    K Number
    K130644
    Device Class
    FDA class 1
    Clearance Type
    Abbreviated
    Regulation Number
    890.3850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Columbia Medical Mfg, LLC
    Date Received
    March 11, 2013
    Decision Date
    October 16, 2013
    Product Code
    LBE
    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
    LBE Stroller, Adaptive

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