QFT

Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder

Product code
QFT
Device name
Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
Device class
Class 2
21 CFR
21 CFR 882.5803
Medical specialty
Obstetrics/Gynecology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
3
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
4 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2025-06-13.

NumberDecision dateApplicantDevice nameSummary
K2437292025-06-13Lumos Labs, Inc.PrismiraPDF
K2334962024-06-14Akili Interactive Labs, Inc.EndeavorOTCFDA
K2313372023-12-13Akili Interactive Labs, Inc.EndeavorRxPDF

2 summaries are archived here for direct download.

Official FDA classification page: QFT
Classification and pathway per current FDA publications. Data from openFDA (CC0).