Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder

QFT · Class II — Moderate Risk (510(k) clearance required) · Obstetrics/Gynecology · 21 CFR 882.5803

Classification

FDA Product Code: QFT
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 882.5803
Review panel: NE
Medical specialty: Obstetrics/Gynecology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 4
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown