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

QGH is the FDA product code for Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder, a class II device type, regulated under 21 CFR 882.5940. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold 9 510(k) clearances under this code, the most recent dated 2020-04-26, and no recalls.