Computerized Behavioral Therapy Device For Anxiety Disorders
A computerized behavioral therapy device for anxiety disorders is a software-based medical device intended to deliver computerized behavioral therapy for the treatment of psychiatric disorders, specifically anxiety disorders, providing a digital therapeutic intervention. It is classified as FDA Class II (510(k) required) under regulation 882.5801 in the Neurology specialty, with product code SCP. The device is not an implant and does not support life-sustaining functions.
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Basic Information
- Product Code
- SCP
- Device Class
- FDA class 2
- Regulation Number
- 882.5801
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
Definition
Computerized behavioral therapy device for psychiatric disorders
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K233872 | Daylight | Aug 30, 2024 | Substantially Equivalent | Big Health, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.