Transcranial Magnetic Stimulation System For Smoking Cessation
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.
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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
Definition
Intended for use as a transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
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.