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510(k) Data Aggregation

    K Number
    DEN220083
    Device Name
    Stanza
    Date Cleared
    2023-05-09

    (169 days)

    Product Code
    Regulation Number
    882.5804
    Why did this record match?
    Applicant Name (Manufacturer) :

    Swing Therapeutics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Stanza is a prescription digital therapeutic that provides Acceptance and Commitment Therapy, a form of Cognitive Behavioral Therapy, and is indicated for the treatment of fibromyalgia symptoms in adult patients.
    Device Description
    Stanza is a prescription-only smartphone-based digital therapy that delivers a self-guided program of Acceptance and Commitment Therapy (ACT), a form of Cognitive Behavioral Therapy (CBT), for patients with fibromyalgia. Stanza is designed to be a 12-week treatment, followed by open access to the program materials for a period of time. Stanza contains 42 unique daily sessions, organized into 8 chapters, which comprise the core program. Once the core program is completed, patients have access to reinforcement sessions, organized into playlists, to strengthen the skill building and reinforce the core program. To use Stanza, patients first download Stanza from the App store or Google Play store and then securely log in and are authorized. Patients go through a brief tutorial of Stanza's major features and exit the tutorial onto the Today page , which is a patient's home base for the treatment program. The core program is organized into eight chapters (Table 1). Each of the eight chapters are intended to train the patient on the core ACT skills: Acceptance, Values, Mindfulness, Defusion, Self-as-Context, and Willingness/Committed Action. Each daily Session may include the following types of interactive activities: - A lesson to build an ACT skill . - . A guided audio awareness activity - A journaling activity to help patients reflect on incorporating ACT skills in their daily lives . - . Self-guided pacing or exercise activity to help patients gradually increase their activity level and physical functioning
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