Product Code: QMD FDA class 2 21 CFR 882.5802

Transcranial Magnetic Stimulation System For Smoking Cessation

Neurology

The Transcranial Magnetic Stimulation System for Smoking Cessation is a non-invasive neuromodulation device intended for use as a transcranial magnetic stimulation system to address neurological and psychiatric disorders and conditions, including as an aid in smoking cessation. It delivers focused magnetic pulses to targeted brain regions to modulate neural activity. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 882.5802 in the Neurology specialty. It carries product code QMD and is not an implant, not life-sustaining, and not GMP exempt.

510(k)s
2
FEI Numbers
1
Registration Numbers
1
Unique Applicants
1
Years Active
1

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Basic Information

Product Code
QMD
Device Class
FDA class 2
Regulation Number
882.5802
Medical Specialty
Neurology
Review Panel
NE
Submission Type
1

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

Definition

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

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 2 510(k) clearances via K numbers.

K Number Device Name
K203616 Brainsway Deep (DTMS) System
K200957 Brainsway Deep TMS System

FEI Numbers

This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.