BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇦🇺 Australia

    PainChek (PainChek Adult)

    K Number: DEN240073 · Decision Oct 6, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    299

    Basic Information

    Device Name
    PainChek (PainChek Adult)
    K Number
    DEN240073
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    882.1472
    Medical Specialty
    Neurology
    Decision
    Unknown
    Applicant
    Painchek Limited (Ltd.)
    Date Received
    December 11, 2024
    Decision Date
    October 6, 2025
    Product Code
    SGB
    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
    SGB Pain Assessment Software In Non-Communicative Adults