BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    actiTENS mini

    K Number: K252767 · Decision Jan 16, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    2
    Review Days
    140

    Basic Information

    Device Name
    actiTENS mini
    K Number
    K252767
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sublimed
    Date Received
    August 29, 2025
    Decision Date
    January 16, 2026
    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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    Other Clearances by Sublimed

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