BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4

    K Number: K251856 · Decision Nov 21, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    29
    Review Days
    157

    Basic Information

    Device Name
    Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4
    K Number
    K251856
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Everyway Medical Instruments Co.,Ltd
    Date Received
    June 17, 2025
    Decision Date
    November 21, 2025
    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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