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510(k) Data Aggregation

    K Number
    K230814
    Device Name
    VRNT
    Manufacturer
    CognifiSense, Inc.
    Date Cleared
    2023-10-31

    (221 days)

    Product Code
    QRA
    Regulation Number
    890.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    CognifiSense, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VRNT is a prescription-use immersive virtual reality system intended to provide adjunctive treatment based on cognitive behavioral therapy skills and other evidence-based behavioral methods for patients (age 18 and older) with a diagnosis of chronic lower back-pain (defined as moderate to severe pain lasting longer than three months). The device is intended for in-home use for the reduction of pain and pain interference associated with chronic lower back pain.
    Device Description
    VRNT is an immersive virtual reality (VR) system which delivers behavioral therapy content for the treatment of chronic pain via virtual reality hardware. VRNT is a prescription-use device containing pre-loaded, proprietary content on commercially available VR hardware shown in the figure below. The behavioral content incorporates cognitive behavioral therapy (CBT) skills and other evidence-based behavioral methods. VRNT uses a virtual reality system called GearVR, consisting of a virtual reality head-mounted display, a hand controller and a smartphone VRNT is designed to be used in an 8-week treatment program which delivers a multifaceted combination of pain management skills training through a sequence of daily sessions (5 days a week) ranging from 7-27 minutes in length (average of 20 minutes). Similar to multisession behavioral treatment program begins with basic skills and progresses to more advanced skills over the 8 weeks. Initial themes in VRNT are focused on understanding the basic science behind chronic pain and developing rudimentary breathing, bodily awareness and mindfulness, relaxation and interoception skills. Later themes build on these skills; they expand on interoception, add passive distraction and refocusing attention, thought appraisal skills for managing emotion triggers. Finally, the program provides opportunities to practice applying the education and self-regulation skills when faced with actual pain triggers. The treatment content, thus, allows the patient over time to build upon education, skills training and their own experiential learning in a manner that increasingly mimics real-world situations.
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