FDA product code QGH: 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. It is a Class II device, regulated under 21 CFR 882.5940 and reviewed by the Neurology panel. FDA has cleared 9 510(k) submissions under QGH, from 5 different applicants. The average 510(k) review took 198 days (median 208).
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.
Classification
| Field | Value |
|---|---|
| Device name | Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder |
| Device class | Class II |
| Regulation | 21 CFR 882.5940 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for QGH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 207 |
Compare with all 510(k) review times · Search every QGH clearance
Top QGH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mecta Corp. | 3 | 1997-03-06 |
| Somatics, Inc. | 2 | 1995-10-26 |
| Elcot, Inc. | 2 | 1991-10-18 |
| Mecta Corporation | 1 | 2020-04-26 |
| Medcraft Corp. | 1 | 1986-11-10 |
Most recent QGH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K192834 | Mecta Corporation | MECTA Sigma | 2020-04-26 | 207 |
| K965070 | Mecta Corp. | SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M. | 1997-03-06 | 85 |
| K960754 | Mecta Corp. | SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M | 1996-09-18 | 208 |
| K945120 | Somatics, Inc. | THYMATRON 2000 ELECTROCONVULSIVE SYSTEM | 1995-10-26 | 372 |
| K911144 | Elcot, Inc. | MF-500, MODIFICATION | 1991-10-18 | 235 |
Recalls for QGH devices
openFDA lists no recalls for product code QGH.
Frequently asked questions
What is FDA product code QGH?
QGH is the FDA product code for electroconvulsive therapy device for catatonia, major depressive disorder, and bipolar disorder. It is a Class II device, regulated under 21 CFR 882.5940 and reviewed by the Neurology panel.
What device class is QGH?
Class II, regulation 21 CFR 882.5940. Typical premarket route: 510(k).
How long does a 510(k) take for product code QGH?
Across 9 cleared submissions the average was 198 days from receipt to decision (median 208).
Which companies have the most QGH clearances?
Mecta Corp. (3); Somatics, Inc. (2); Elcot, Inc. (2); Mecta Corporation (1); Medcraft Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QGH
- Run a recall and safety report across every QGH manufacturer
- Watch product code QGH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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