Computerized Behavioral Therapy Device For Depressive Disorders.
A computerized behavioral therapy device for depressive disorders is a software-based medical device intended to deliver computerized behavioral therapy as a treatment for depressive disorders, providing a digital therapeutic intervention for patients with depression. It is classified as FDA Class II (510(k) required) under regulation 882.5801 in the Neurology specialty, with product code SAP. The device is not an implant and does not support life-sustaining functions.
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Basic Information
- Product Code
- SAP
- 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 computerized behavioral therapy to treat depressive disorders.
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 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.