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FDA PRODUCT CODE · CLASS II

PWE — Computerized Behavioral Therapy Device For Substance Use Disorders

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

DEVICE CLASS
Class II
REGULATION
21 CFR 882.5801
MEDICAL SPECIALTY
Neurology
REVIEW PANEL
NE
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

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Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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