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

    Wireless TENS & EMS (Model SM9110,SM9113,SM9116)

    K Number: K233067 · Decision Jul 19, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    4
    Review Days
    297

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    Basic Information

    Device Name
    Wireless TENS & EMS (Model SM9110,SM9113,SM9116)
    K Number
    K233067
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Chongqing Rob Linka Science and Technology Co., Ltd.
    Date Received
    September 26, 2023
    Decision Date
    July 19, 2024
    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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