DeviceClearance

Product code PWE— Neurology

reSET-O

Classification name
Computerized Behavioral Therapy Device For Substance Use Disorders
Device class
Class 2
Regulation
21 CFR 882.5801
Advisory panel
Neurology
Total cleared
2
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code PWE under 21 CFR 882.5801, via openFDA

Market context for product code PWE

FDA has cleared 2 devices under product code PWE between 2017 and 2018, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PWE

Recent clearances under product code PWE

Data sourced from openFDA. This site is unofficial and independent of the FDA.