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

    EMS/TENS Massager Device

    K Number: K233040 · Decision Feb 12, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    7
    Review Days
    140

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    Basic Information

    Device Name
    EMS/TENS Massager Device
    K Number
    K233040
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shenzhen Imdk Medical Technology Co., Ltd.
    Date Received
    September 25, 2023
    Decision Date
    February 12, 2024
    Product Code
    NUH
    Advisory Committee
    Neurology
    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
    NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

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