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U.S. Department of Health and Human Services

Product Classification
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Device computerized behavioral therapy device for substance use disorders
Regulation Description Computerized behavioral therapy device for psychiatric disorders.
Definition The device is intended to provide cognitive behavioral therapy to treat substance use disorder.
Physical State The device is a software-based mobile app downloaded onto a smartphone.
Technical Method The device is a software-based mobile app that provides a computerized version of behavioral therapy to the patient.
Target Area The device is intended to provided psychiatric treatment.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodePWE
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type 510(k)
Regulation Number 882.5801
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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