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

    AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)

    K Number: K222867 · Decision Dec 21, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    92
    Review Days
    90

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    Basic Information

    Device Name
    AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)
    K Number
    K222867
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Andon Health Co, Ltd.
    Date Received
    September 22, 2022
    Decision Date
    December 21, 2022
    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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