QGH
9 FDA 510(k) clearances · Product code
208 daysmedian time to decision
372 days90th percentile
9clearances measured
FDA profile
- Official device name
- Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5940
- Medical specialty
- Neurology
- FDA 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.
- Adverse events (MAUDE)
- 2022: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MECTA Sigma (K192834) | Mecta Corporation | 2020-04-26 |
| SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M. (K965070) | Mecta Corp. | 1997-03-06 |
| SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M (K960754) | Mecta Corp. | 1996-09-18 |
| THYMATRON 2000 ELECTROCONVULSIVE SYSTEM (K945120) | Somatics, Inc. | 1995-10-26 |
| MF-500, MODIFICATION (K911144) | Elcot, Inc. | 1991-10-18 |
| ELECTROCONVULSIVE THERAPY DEVICE, MODEL MF-1000 (K863815) | Elcot, Inc. | 1987-06-02 |
| ELECTROSHOCK UNIT NEUROLOGY MODEL B-25 (K860467) | Medcraft Corp. | 1986-11-10 |
| MECTA ECT DEVICE MODELS SR & JR (K852069) | Mecta Corp. | 1985-08-09 |
| THYMATRON (K843923) | Somatics, Inc. | 1984-12-03 |
Track QGH automatically
Every clearance here is in the API, with alerts when new ones post.