QFT — Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder Class II
FDA product code QFT covers "Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder", a Class II medical device regulated under 21 CFR 882.5803. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QFT
- Device Class
- Class II
- Regulation Number
- 882.5803
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
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.