# QGH: Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder

- Device class: 2; regulation: 21 CFR 882.5940; FDA's rule: 510(k) required
- FDA decisions: 9
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1984: 1
- 1985: 1
- 1986: 1
- 1987: 1
- 1991: 1
- 1995: 1
- 1996: 1
- 1997: 1
- 2020: 1

## Most-cited predicates
- K960754: Spectrum 5000 Q, 5000 M, 4000 Q, 4000 M (1996), cited by 1
- K852069: Mecta Ect Device Models SR & JR (1985), cited by 1

Source page: https://510kreport.com/product-code/QGH
Data by year (CSV): https://510kreport.com/product-code/QGH.csv