Atlas FDA

QFT

4 FDA 510(k) clearances · Product code

FDA profile

Official device name
Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5803
Medical specialty
Obstetrics/Gynecology
FDA 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.
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RecordFirmDate
Prismira (K243729)Lumos Labs, Inc.2025-06-13
EndeavorOTC (K233496)Akili Interactive Labs, Inc.2024-06-14
EndeavorRx (K231337)Akili Interactive Labs, Inc.2023-12-13
EndeavorRx (DEN200026)Akili Interactive Labs, Inc.2020-06-15

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Every clearance here is in the API, with alerts when new ones post.