BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Enso for Migraine

    K Number: K254216 · Decision Apr 16, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    17
    Applicant Total
    2
    Review Days
    108

    Basic Information

    Device Name
    Enso for Migraine
    K Number
    K254216
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5891
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hinge Health, Inc.
    Date Received
    December 29, 2025
    Decision Date
    April 16, 2026
    Product Code
    PCC
    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
    PCC Stimulator, Nerve, Electrical, Transcutaneous, For Migraine

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