Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
The Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder is indicated for the treatment of catatonia or severe major depressive episodes associated with major depressive disorder or bipolar disorder in patients age 13 years and older who are treatment-resistant or require a rapid response due to the severity of their psychiatric or medical condition. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 882.5940 in the Neurology specialty. The product code is QGH. It is not an implant and is not life-sustaining.
Basic Information
- Product Code
- QGH
- Device Class
- FDA class 2
- Regulation Number
- 882.5940
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K192834 | MECTA Sigma | Apr 26, 2020 | Substantially Equivalent | Mecta Corporation |
| K965070 | SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M. | Mar 06, 1997 | Substantially Equivalent | Mecta Corp. |
| K960754 | SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M | Sep 18, 1996 | Substantially Equivalent | Mecta Corp. |
| K945120 | THYMATRON 2000 ELECTROCONVULSIVE SYSTEM | Oct 26, 1995 | Substantially Equivalent | Somatics, Inc. |
| K911144 | MF-500, MODIFICATION | Oct 18, 1991 | Substantially Equivalent | Elcot, Inc. |
| K863815 | ELECTROCONVULSIVE THERAPY DEVICE, MODEL MF-1000 | Jun 02, 1987 | Substantially Equivalent | Elcot, Inc. |
| K860467 | ELECTROSHOCK UNIT NEUROLOGY MODEL B-25 | Nov 10, 1986 | Substantially Equivalent | Medcraft Corp. |
| K852069 | MECTA ECT DEVICE MODELS SR & JR | Aug 09, 1985 | Substantially Equivalent | Mecta Corp. |
| K843923 | THYMATRON | Dec 03, 1984 | Substantially Equivalent | Somatics, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.