FDA product code QGH

Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder

Neurology·Class 2·21 CFR 882.5940
US regulatory classifications
US Product Code (FDA)
QGH
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 882.5940
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Medical specialty
Neurology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder is a medical device type in the Neurology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.