BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”)

    K Number: K253055 · Decision Jun 17, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    12
    Applicant Total
    1
    Review Days
    268

    Basic Information

    Device Name
    Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”)
    K Number
    K253055
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1950
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nordic Kinetics AB
    Date Received
    September 22, 2025
    Decision Date
    June 17, 2026
    Product Code
    GYD
    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
    GYD Transducer, Tremor

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