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

    Electrical Stimulator System

    K Number: K192201 · Decision Jun 12, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    2
    Review Days
    304

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    Basic Information

    Device Name
    Electrical Stimulator System
    K Number
    K192201
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gymmax Technology Shenzen Co., Ltd.
    Date Received
    August 13, 2019
    Decision Date
    June 12, 2020
    Product Code
    NUH
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

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    Other Clearances by Gymmax Technology Shenzen Co., Ltd.

    K Number Device Name
    K232439 Electrical Stimulator System