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U.S. Department of Health and Human Services

Product Classification

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Device transcranial magnetic stimulation system for smoking cessation
Regulation Description Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
Definition Intended for use as a transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
Physical State Repetitive transcranial magnetic stimulation system
Technical Method Applies transcranial pulsed magnetic stimulation to the cortex of the brain
Target Area Prefrontal cortex of the brain
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeQMD
Premarket Review Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type 510(k)
Regulation Number 882.5802
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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