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U.S. Department of Health and Human Services

Product Classification

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Device cranial electrotherapy stimulator to treat depression
Regulation Description Cranial electrotherapy stimulator.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeJXK
Premarket Review Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type PMA
Regulation Number 882.5800
Device Class 3
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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