QFT — Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder Class II

FDA Device Classification

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243729lumos labsPrismiraJune 13, 2025
K233496akili interactive labsEndeavorOTCJune 14, 2024
K231337akili interactive labsEndeavorRxDecember 13, 2023
DEN200026akili interactive labsEndeavorRxJune 15, 2020