# K960754: Spectrum 5000 Q, 5000 M, 4000 Q, 4000 M

- Pathway: 510(k) (Traditional)
- Applicant: Mecta Corp.
- Decided: Sep 18, 1996 after 208 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
Longest line of descent: 1 generation back to K852069 (1985). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K852069: Mecta Ect Device Models SR & JR, Mecta Corp. (1985) Summary page 7.

## Most influential descendants
- K965070: Spectrum  5000 Q, 5000Q,M,4000 Q, 4000 M. (1997), 0 descendants of its own

## Indications for use
The intended use of the MECTA spECTrum device is solely for the treatment of "severe depression" or "major depressive episode with melancholia". (ref CFR Part 882 Part III). The clinical setting is in hospital ECT suites, Operating Rooms, or on patient wards.

Source page: https://510kreport.com/device/K960754
Methodology: https://510kreport.com/methodology