BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM

    K Number: K060150 · Decision Feb 23, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    34

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    Basic Information

    Device Name
    SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM
    K Number
    K060150
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    890.5575
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Andante Medical Devices , Ltd.
    Date Received
    January 20, 2006
    Decision Date
    February 23, 2006
    Product Code
    IRN
    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
    IRN Device, Warning, Overload, External Limb, Powered

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