QFT
- 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.
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K243729 | 2025-06-13 | Lumos Labs, Inc. | Prismira | |
| K233496 | 2024-06-14 | Akili Interactive Labs, Inc. | EndeavorOTC | FDA |
| K231337 | 2023-12-13 | Akili Interactive Labs, Inc. | EndeavorRx |
Official FDA classification page: QFT
Classification and pathway per current FDA publications. Data from openFDA (CC0).