Computerized Behavioral Therapy Device For Insomnia
The Computerized Behavioral Therapy Device for Insomnia is a software-based device intended to deliver cognitive behavioral therapy for insomnia (CBT-I), a structured, evidence-based psychological treatment, through a digital platform to help patients improve sleep patterns and address the underlying thoughts and behaviors contributing to insomnia. Classified as FDA Class 2 under regulation 882.5801, it requires 510(k) clearance in the Neurology specialty. It is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QVO
- Device Class
- FDA class 2
- Regulation Number
- 882.5801
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
Definition
The device is intended to provide cognitive behavioral therapy to treat insomnia.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.