DeviceClearance

Product code QMD— Neurology

Brainsway Deep (DTMS) System

Classification name
Transcranial Magnetic Stimulation System For Smoking Cessation
Device class
Class 2
Regulation
21 CFR 882.5802
Advisory panel
Neurology
Total cleared
2
First cleared
Most recent

FDA classification definition

“Intended for use as a transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.”

— U.S. Food and Drug Administration, device classification record for product code QMD under 21 CFR 882.5802, via openFDA

Market context for product code QMD

FDA has cleared 2 devices under product code QMD between 2020 and 2021, filed by 1 applicant company. 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 QMD

Recent clearances under product code QMD

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