BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    JOURNEY (OR RPSP), JOURNEY CUBIC (OR SUPRA OR TP02)

    K Number: K090856 · Decision May 27, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    28
    Applicant Total
    2
    Review Days
    58

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    Basic Information

    Device Name
    JOURNEY (OR RPSP), JOURNEY CUBIC (OR SUPRA OR TP02)
    K Number
    K090856
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3930
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Thyssenkrupp Ceteco Srl
    Date Received
    March 30, 2009
    Decision Date
    May 27, 2009
    Product Code
    ING
    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
    ING Elevator, Wheelchair, Portable

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