MECTA Sigma
FDA 510(k) K192834 · Mecta Corporation
510(k) numberK192834
Submission
- Device name
- MECTA Sigma
- Applicant
- Mecta Corporation
Suite B, OR, US - Received
- October 2, 2019
- Decision date
- April 26, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- QGH – Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5940
- Specialty
- Neurology
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.
Other 510(k)s with product code QGH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K965070 | Spectrum 5000 Q, 5000Q,M,4000 Q, 4000 M.QGH · Traditional | Mecta Corp. | 03/06/1997SE |
| K960754 | Spectrum 5000 Q, 5000 M, 4000 Q, 4000 MQGH · Traditional | Mecta Corp. | 09/18/1996SE |
| K945120 | Thymatron 2000 Electroconvulsive SystemQGH · Traditional | Somatics, Inc. | 10/26/1995SE |
| K911144 | MF-500, ModificationQGH · Traditional | Elcot, Inc. | 10/18/1991SE |
| K863815 | Electroconvulsive Therapy Device, Model MF-1000QGH · Traditional | Elcot, Inc. | 06/02/1987SE |
| K860467 | Electroshock Unit Neurology Model B-25QGH · Traditional | Medcraft Corp. | 11/10/1986SE |
| K852069 | Mecta Ect Device Models SR & JRQGH · Traditional | Mecta Corp. | 08/09/1985SE |
| K843923 | ThymatronQGH · Traditional | Somatics, Inc. | 12/03/1984SE |
More from Somatics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K201309 | ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size MediumJXL · Traditional | 06/04/2021SE |
| K965070 | Spectrum 5000 Q, 5000Q,M,4000 Q, 4000 M.QGH · Traditional | 03/06/1997SE |
| K960754 | Spectrum 5000 Q, 5000 M, 4000 Q, 4000 MQGH · Traditional | 09/18/1996SE |
| K852069 | Mecta Ect Device Models SR & JRQGH · Traditional | 08/09/1985SE |
Questions and answers
When was MECTA Sigma cleared by the FDA?
MECTA Sigma (K192834) received a 510(k) decision of Substantially Equivalent on April 26, 2020, 207 days after the submission was received.
What is the product code of K192834?
The FDA product code is QGH – Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder, a Class II (moderate risk) device regulated under 21 CFR 882.5940.