| 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 |
