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U.S. Department of Health and Human Services

Product Classification
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Device transcutaneous nerve stimulator for adhd
Regulation Description Transcutaneous electrical nerve stimulator for attention deficit hyperactivity disorder.
Definition A transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder (ADHD) is a prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead.
Physical State External pulse generator with wire leads connected to an electrode.
Technical Method The device will generate electrical waveforms wich when applied to the intended target will improve symptoms associated with ADHD.
Target Area Cranial and/or peripheral nerves.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeQGL
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Rehabilitation Devices (DHT5B)
Submission Type 510(k)
Regulation Number 882.5898
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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