PWE — Computerized Behavioral Therapy Device For Substance Use Disorders Class II

FDA Device Classification

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K173681pear therapeuticsreSET-ODecember 10, 2018
DEN160018pear therapeuticsreSetSeptember 14, 2017