QMD — Transcranial Magnetic Stimulation System For Smoking Cessation Class II

FDA Device Classification

FDA product code QMD covers "Transcranial Magnetic Stimulation System For Smoking Cessation", a Class II medical device regulated under 21 CFR 882.5802. Submissions are reviewed by the Neurology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
QMD
Device Class
Class II
Regulation Number
882.5802
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K203616brainswayBrainsway Deep (DTMS) SystemApril 16, 2021
K200957brainswayBrainsway Deep TMS SystemAugust 21, 2020