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U.S. Department of Health and Human Services

Product Classification

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Device digital therapeutic software for attention deficit hyperactivity disorder
Definition A digital therapy device for Attention Deficit Hyperactivity Disorder (ADHD) is a software intended to provide therapy for ADHD or any of its individual symptoms as an adjunct to clinician supervised treatment.
Physical State Digital video game-like software device that delivers a creative and immersive action video game experience. The treatment looks and feels like a high-end video game, leveraging art, music, storytelling, and reward cycles to keep patients engaged and immersed while the design constantly pushes patients precisely at pre-defined performance bounds relative to each patient, such that they are continuously encouraged to exceed their historic performance.
Technical Method Digital videogame like software device
Target Area Brain
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Neurology
Product CodeQFT
Premarket Review Neuromodulation and Physical Medicine Devices (DHT5B)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type 510(k)
Regulation Number 882.5803
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible