Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K233872
    Device Name
    Daylight
    Manufacturer
    Big Health, Inc.
    Date Cleared
    2024-08-30

    (267 days)

    Product Code
    SCP, DAY
    Regulation Number
    882.5801
    Why did this record match?
    Applicant Name (Manufacturer) :

    Big Health, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Daylight is a prescription device delivering Cognitive Behavioral Therapy and can be made available on the order of a licensed healthcare provider. Daylight is a digital therapeutic intended to treat generalized anxiety disorder (GAD) by improving a patient's GAD symptoms as an adjunct to usual care in patients aged 22 years and older.
    Device Description
    Daylight is a digital therapeutic designed to address the symptoms of adults with generalized anxiety disorder (GAD) through the use of Cognitive Behavioral Therapy (CBT) techniques. The Daylight program is has been demonstrated to help improve symptoms of GAD, if followed correctly, and is supported by evidence from peer-reviewed studies and clinical trials. The program is delivered digitally through the Daylight iOS/Android apps, giving users easy access to effective techniques.
    Ask a Question
    K Number
    K233577
    Device Name
    Sleepio®
    Manufacturer
    Big Health, Inc.
    Date Cleared
    2024-08-05

    (272 days)

    Product Code
    QVO
    Regulation Number
    882.5801
    Why did this record match?
    Applicant Name (Manufacturer) :

    Big Health, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sleepio is a digital therapeutic intended for the treatment of chronic insomnia disorder as an adjunct to usual care in patients aged 18 and older. Sleepio is a prescription device delivering Cognitive Behavioral Therapy for Insomnia (CBT-I) and can be made available on the order of a licensed healthcare provider.
    Device Description
    Sleepio is a digital therapeutic for the treatment of chronic insomnia / insomnia disorder. Sleepio treats chronic insomnia disorder by delivering evidence-based techniques targeting the cognitive and behavioral factors that maintain insomnia and chronic sleep problems. Patient experience is tailored based on symptoms and daily sleep tracking. In addition to core therapeutic components, there is in-the-moment therapeutic content for help falling asleep. Content is delivered via smartphone and tablet applications (iOS and Android), as well as via web. Sleepio is intended as an adjunct to usual care treatment for chronic insomnia / insomnia disorder by a healthcare provider. Healthcare providers have access to a dashboard to track patient engagement with Sleepio.
    Ask a Question

    Page 1 of 1