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

    RENEGADE WHEELCHAIR

    K Number: K082857 · Decision Jan 6, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    23
    Applicant Total
    1
    Review Days
    99

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    Basic Information

    Device Name
    RENEGADE WHEELCHAIR
    K Number
    K082857
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3880
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alpha One
    Date Received
    September 29, 2008
    Decision Date
    January 6, 2009
    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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