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Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder

Page Type
Product Code
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
Obstetrical and Gynecological
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5803
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QFT is linked to regulation 21CFR882.5803, which does not seem to exist yet. It may be pending at the moment.

Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder

Page Type
Product Code
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
Obstetrical and Gynecological
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5803
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QFT is linked to regulation 21CFR882.5803, which does not seem to exist yet. It may be pending at the moment.