PWE — Computerized Behavioral Therapy Device For Substance Use Disorders Class II
FDA product code PWE covers "Computerized Behavioral Therapy Device For Substance Use Disorders", a Class II medical device regulated under 21 CFR 882.5801. Submissions are reviewed by the Neurology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PWE
- Device Class
- Class II
- Regulation Number
- 882.5801
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Definition
The device is intended to provide cognitive behavioral therapy to treat substance use disorder.