# K965070: Spectrum  5000 Q, 5000Q,M,4000 Q, 4000 M.

- Pathway: 510(k) (Traditional)
- Applicant: Mecta Corp.
- Decided: Mar 6, 1997 after 85 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: 2 generations back to K852069 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960754: Spectrum 5000 Q, 5000 M, 4000 Q, 4000 M, Mecta Corp. (1996) Summary page 7.

## Indications for use
Treatment of “severe depression® ar "major depressive episcde with melancholia”.

Source page: https://510kreport.com/device/K965070
Methodology: https://510kreport.com/methodology