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

Transcranial Magnetic Stimulation System For Smoking Cessation

21 CFR 882.5802 / Neurology
FDA source (opens on fda.gov)

QMD is the FDA product code for Transcranial Magnetic Stimulation System For Smoking Cessation, a class II device type, regulated under 21 CFR 882.5802. FDA's definition for this code reads: "Intended for use as a transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QMD
Device name
Transcranial Magnetic Stimulation System For Smoking Cessation
FDA definition
Intended for use as a transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
Regulation
21 CFR 882.5802
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QMD

By decision year
2 clearances under product code QMD with a decision year between 2020 and 2021, 2020 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QMD by decision year
YearClearances
20201
20211

Applicants with the most clearances

Product code QMD
Applicants holding the most 510(k) clearances under product code QMD
ApplicantClearances
Brainsway Ltd.2

Companies listing this code with FDA

Companies whose registered establishments list this code