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

    Jintronix

    K Number: K143034 · Decision Apr 22, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    26
    Applicant Total
    2
    Review Days
    182

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    Basic Information

    Device Name
    Jintronix
    K Number
    K143034
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5360
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jintronix, Inc.
    Date Received
    October 22, 2014
    Decision Date
    April 22, 2015
    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 Jintronix, Inc.

    K Number Device Name
    K130847 JINTRONIX REHABILITATION SYSTEM (JRS)