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U.S. Department of Health and Human Services

Product Classification
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Device cranial electrotherapy stimulator to treat insomnia and/or anxiety
Regulation Description Cranial electrotherapy stimulator.
Definition To provide electrical current to the head to treat insomnia and/or anxiety
Physical State Electrodes and an electrical stimulus generator
Technical Method Electrodes placed on the head of the patient and electrical generator applies an electrical current trancutaneously to the head
Target Area Cranial nerves
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeQJQ
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type 510(k)
Regulation Number 882.5800
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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