PWE · Class II · 21 CFR 882.5801

FDA Product Code PWE: Computerized Behavioral Therapy Device For Substance Use Disorders

The Device Is Intended To Provide Cognitive Behavioral Therapy To Treat Substance Use Disorder.

Leading manufacturers include Pear Therapeutics, Inc..

2
Total
1
Cleared
430d
Avg days
2017
Since

FDA 510(k) Cleared Computerized Behavioral Therapy Device For Substance Use Disorders Devices (Product Code PWE)

2 devices
1–2 of 2
Cleared Dec 10, 2018
reSET-O
K173681
Pear Therapeutics, Inc.
Neurology · 374d
Not Cleared Sep 14, 2017
reSet
DEN160018
Pear Therapeutics, Inc.
Neurology · 486d

About Product Code PWE - Regulatory Context