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

    Portable Neuromodulation Stimulator (PoNS)

    K Number: K253061 · Decision May 13, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    233

    Basic Information

    Device Name
    Portable Neuromodulation Stimulator (PoNS)
    K Number
    K253061
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5889
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Helius Medical, Inc.
    Date Received
    September 22, 2025
    Decision Date
    May 13, 2026
    Product Code
    QCF
    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
    QCF Electrical Tongue Stimulator To Treat Motor Deficits

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QCF), ordered by most recent decision date.

    Portable Neuromodulation Stimulator (PoNS)

    FDA 510(k)
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    Other Clearances by Helius Medical, Inc.

    K Number Device Name
    DEN200050 Portable Neuromodulation Stimulator (PoNS)