510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QFTClass II

Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder

21 CFR 882.5803 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

QFT is the FDA product code for Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder, a class II device type, regulated under 21 CFR 882.5803. FDA's definition for this code reads: "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". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QFT
Device name
Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
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.
Regulation
21 CFR 882.5803
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code QFT

By decision year
4 clearances under product code QFT with a decision year between 2020 and 2025, 2020 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QFT by decision year
YearClearances
20201
20231
20241
20251

Applicants with the most clearances

Product code QFT
Applicants holding the most 510(k) clearances under product code QFT
ApplicantClearances
Akili Interactive Labs, Inc.3
Lumos Labs, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code