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U.S. Department of Health and Human Services

Product Classification

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Device device, electroconvulsive therapy
Regulation Description Electroconvulsive therapy device.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeGXC
Premarket Review Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type PMA
Regulation Number 882.5940
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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