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U.S. Department of Health and Human Services

Product Classification
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Device electroconvulsive therapy device for catatonia, major depressive disorder, and bipolar disorder
Regulation Description Electroconvulsive therapy device.
Definition Catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition.
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 to the head
Target Area Brain
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeQGH
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type 510(k)
Regulation Number 882.5940
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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