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 Code | QFT |
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 Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |