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

    Electrical Neuromuscular Stimulator, Cure Trio

    K Number: K233046 · Decision Apr 19, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    5
    Review Days
    207

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    Basic Information

    Device Name
    Electrical Neuromuscular Stimulator, Cure Trio
    K Number
    K233046
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Oriental Inspiration Limited
    Date Received
    September 25, 2023
    Decision Date
    April 19, 2024
    Product Code
    GZJ
    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
    GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

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