PWE

Computerized Behavioral Therapy Device For Substance Use Disorders

Product code

PWE

Device name

Computerized Behavioral Therapy Device For Substance Use Disorders

Device class

Class 2

21 CFR

21 CFR 882.5801

Medical specialty

Neurology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification definition

The device is intended to provide cognitive behavioral therapy to treat substance use disorder.

Definition text from the FDA device classification database (U.S. federal government work, public domain).