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

    TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM

    K Number: K063728 · Decision Apr 4, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    54
    Applicant Total
    2
    Review Days
    110

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    Basic Information

    Device Name
    TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM
    K Number
    K063728
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alfa Tech Medical Systems, Ltd.
    Date Received
    December 15, 2006
    Decision Date
    April 4, 2007
    Product Code
    IMG
    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
    IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

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    Other Clearances by Alfa Tech Medical Systems, Ltd.

    K Number Device Name
    K052340 DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEM