BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    JAZZY ELITE 6

    K Number: K113488 · Decision Apr 18, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    550
    Applicant Total
    2
    Review Days
    147

    Basic Information

    Device Name
    JAZZY ELITE 6
    K Number
    K113488
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    PRIDE MOBILITY PRODUCT CORPORRATION
    Date Received
    November 23, 2011
    Decision Date
    April 18, 2012
    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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