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

    SMART (SMART-D, SMART-DX)

    K Number: K131660 · Decision Apr 17, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    26
    Applicant Total
    2
    Review Days
    315

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    Basic Information

    Device Name
    SMART (SMART-D, SMART-DX)
    K Number
    K131660
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5360
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bts S.P.A.
    Date Received
    June 6, 2013
    Decision Date
    April 17, 2014
    Product Code
    LXJ
    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
    LXJ Interactive Rehabilitation Exercise Devices

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    Other Clearances by Bts S.P.A.

    K Number Device Name
    K161716 TEETHAN 2.0