# K192834: MECTA Sigma

- Pathway: 510(k) (Special)
- Applicant: Mecta Corporation
- Decided: Apr 26, 2020 after 207 days
- Product code: QGH (Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder)
- Device class: 2
- Regulation: 21 CFR 882.5940
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The MECTA Sigma ECT device is for use in treating catatonia or severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years or older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition.

Source page: https://510kreport.com/device/K192834
Methodology: https://510kreport.com/methodology