Product code QGH— Neurology
ELECTROCONVULSIVE THERAPY DEVICE, MODEL MF-1000
- Classification name
- Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
- Device class
- Class 2
- Regulation
- 21 CFR 882.5940
- Advisory panel
- Neurology
- Total cleared
- 9
- First cleared
- Most recent
FDA classification definition
“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.”
Market context for product code QGH
FDA has cleared devices under product code QGH between 1984 and 2020, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2020
- 1997
- 1996
- 1995
- 1991
- 1987
- 1986
- 1985
- 1984
Top applicants under product code QGH
Recent clearances under product code QGH
- K192834 — MECTA Sigma
- K965070 — SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M.
- K960754 — SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M
- K945120 — THYMATRON 2000 ELECTROCONVULSIVE SYSTEM
- K911144 — MF-500, MODIFICATION
- K863815 — ELECTROCONVULSIVE THERAPY DEVICE, MODEL MF-1000
- K860467 — ELECTROSHOCK UNIT NEUROLOGY MODEL B-25
- K852069 — MECTA ECT DEVICE MODELS SR & JR
- K843923 — THYMATRON
Data sourced from openFDA. This site is unofficial and independent of the FDA.