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

    Stanza

    K Number: DEN220083 · Decision May 9, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    169

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    Basic Information

    Device Name
    Stanza
    K Number
    DEN220083
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    882.5804
    Medical Specialty
    Neurology
    Decision
    Unknown
    Applicant
    Swing Therapeutics, Inc.
    Date Received
    November 21, 2022
    Decision Date
    May 9, 2023
    Product Code
    QWI
    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
    QWI Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms