Computerized Behavioral Therapy Device For Substance Use Disorders
The Computerized Behavioral Therapy Device For Substance Use Disorders is a neurology software-based device intended to deliver cognitive behavioral therapy (CBT) for the treatment of substance use disorder, providing a digital therapeutic intervention that can complement or supplement traditional counseling approaches. It is classified as FDA Class II under regulation 21 CFR 882.5801, requiring 510(k) premarket notification clearance and compliance with general and special controls. The product code is PWE and it falls under the Neurology medical specialty. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- PWE
- 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 substance use disorder.
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 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.