Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification
  • Print
  • Share
  • E-mail
-
New Search Back to Search Results
Device device, electroconvulsive therapy
Regulation Description Electroconvulsive therapy device.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeGXC
Premarket Review Neuromodulation and Rehabilitation Devices (DHT5B)
Neuromodulation and Rehabilitation 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		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
-
-