QGH — Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder Class II
Classification Details
- Product Code
- QGH
- Device Class
- Class II
- Regulation Number
- 882.5940
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K192834 | mecta corporation | MECTA Sigma | April 26, 2020 |
| K965070 | mecta | SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M. | March 6, 1997 |
| K960754 | mecta | SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M | September 18, 1996 |
| K945120 | somatics | THYMATRON 2000 ELECTROCONVULSIVE SYSTEM | October 26, 1995 |
| K911144 | elcot | MF-500, MODIFICATION | October 18, 1991 |
| K863815 | elcot | ELECTROCONVULSIVE THERAPY DEVICE, MODEL MF-1000 | June 2, 1987 |
| K860467 | medcraft | ELECTROSHOCK UNIT NEUROLOGY MODEL B-25 | November 10, 1986 |
| K852069 | mecta | MECTA ECT DEVICE MODELS SR & JR | August 9, 1985 |
| K843923 | somatics | THYMATRON | December 3, 1984 |