Product code PWE
- Device name
- Computerized Behavioral Therapy Device For Substance Use Disorders
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.5801
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- The device is intended to provide cognitive behavioral therapy to treat substance use disorder.
- Source
- FDA openFDA device classification dataset