FDA product code PWE
Computerized Behavioral Therapy Device For Substance Use Disorders
Neurology·Class 2·21 CFR 882.5801
US regulatory classifications
- US Product Code (FDA)
- PWEView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 882.5801View CFR Regulation →
- Medical specialty
- Neurology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
The device is intended to provide cognitive behavioral therapy to treat substance use disorder.
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About this record
Computerized Behavioral Therapy Device For Substance Use Disorders is a medical device type in the Neurology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.