BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    MyOnyx System

    K Number: K201014 · Decision Jan 13, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    95
    Applicant Total
    22
    Review Days
    271

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    Basic Information

    Device Name
    MyOnyx System
    K Number
    K201014
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5320
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Thought Technology , Ltd.
    Date Received
    April 17, 2020
    Decision Date
    January 13, 2021
    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 Thought Technology , Ltd.

    K Number Device Name
    K213197 MyOnyx System
    K053434 MYOTRAC INFINITI ELECTRICAL STIMULATOR
    K053266 MYOTRAC INFINITI
    K925681 MYOTRAC2D/CS
    K932149 THOUGHT TECHNOLOGY VAGINAL & RECTAL ELECTRODE
    K935213 INCONTROL
    K915858 MYOTRAC2
    K915859 MYOTRAC/S, MYODAC/S
    K913898 MYOTRAC+/S, MYODAC+/S
    K903497 FLEXCOMP DSP & PROCOMP
    Search all 22 clearances from Thought Technology , Ltd. →