510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PWEClass II

Computerized Behavioral Therapy Device For Substance Use Disorders

21 CFR 882.5801 / Neurology
FDA source (opens on fda.gov)

PWE is the FDA product code for Computerized Behavioral Therapy Device For Substance Use Disorders, a class II device type, regulated under 21 CFR 882.5801. FDA's definition for this code reads: "The device is intended to provide cognitive behavioral therapy to treat substance use disorder". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
PWE
Device name
Computerized Behavioral Therapy Device For Substance Use Disorders
FDA definition
The device is intended to provide cognitive behavioral therapy to treat substance use disorder.
Regulation
21 CFR 882.5801
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
2

Clearances, product code PWE

By decision year
2 clearances under product code PWE with a decision year between 2017 and 2018, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PWE by decision year
YearClearances
20171
20181

Applicants with the most clearances

Product code PWE
Applicants holding the most 510(k) clearances under product code PWE
ApplicantClearances
Pear Therapeutics, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code