BEUDAMED
    Product Code: SEE FDA class 2 21 CFR 882.5806

    Computerized Behavioral Therapy Device For Migraine

    Neurology

    A computerized behavioral therapy device for migraine is a prescription neurological device intended to provide a computerized version of behavioral therapy for the treatment of headache, offering a non-pharmacological digital therapeutic option for patients with migraines or other headache disorders. It is classified as FDA Class II (510(k) required) under regulation 882.5806 in the Neurology specialty, with product code SEE. The device is not an implant and does not support life-sustaining functions.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    SEE
    Device Class
    FDA class 2
    Regulation Number
    882.5806
    Medical Specialty
    Neurology
    Review Panel
    NE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    A computerized behavioral therapy device for headache is a prescription device intended to provide a computerized version of behavioral therapy for the treatment of headache.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    DEN240064 CT-132