BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15

    K Number: K161055 · Decision Jul 12, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    95
    Applicant Total
    5
    Review Days
    89

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    Basic Information

    Device Name
    Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15
    K Number
    K161055
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5320
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fuji Dynamics , Ltd.
    Date Received
    April 14, 2016
    Decision Date
    July 12, 2016
    Product Code
    KPI
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KPI Stimulator, Electrical, Non-Implantable, For Incontinence

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    Other Clearances by Fuji Dynamics , Ltd.

    K Number Device Name
    K152676 FD TENS 2090, FD TENS 2095
    K152374 LL TENS 160A, LL TENS 160B
    K111654 FD TENS 2070
    K111645 FD TENS 2050 OR SLIDE TENS MODEL FD2050