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U.S. Department of Health and Human Services

Product Classification

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Device cognitive 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 Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurodiagnostic and Neurosurgical Devices Branch (NDNB)
Submission Type 510(k)
Regulation Number 882.5801
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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