DeviceClearance

Product code QFT— Obstetrics/Gynecology

EndeavorRx

Classification name
Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
Device class
Class 2
Regulation
21 CFR 882.5803
Advisory panel
Obstetrics/Gynecology
Total cleared
4
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QFT under 21 CFR 882.5803, via openFDA

Market context for product code QFT

FDA has cleared 4 devices under product code QFT between 2020 and 2025, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QFT

Recent clearances under product code QFT

Data sourced from openFDA. This site is unofficial and independent of the FDA.