Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
Neurology · 21 CFR 882.5940
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.
Recent MDR events
34 adverse event reports on file
- ELECTROCONVULSIVE THERAPY DEVICEMay 20, 2025InjurySomatics, Llc.MW5170609
- EPAD THYMAPAD STIMULUS ELECTRODENov 26, 2024MalfunctionSomatics, Llc20782367
- THYMATRONJul 10, 2024InjurySomatics, Llc.MW5157194
- THYMATRONApr 23, 2024InjurySomatics, Llc.MW5154064
- ECTONUSTIMApr 5, 2024InjuryEctron LimitedMW5153618
- MECTA SIGMAFeb 29, 2024InjuryMecta Llc3020533-2024-00001
- ECT MACHINEFeb 27, 2024InjuryUnknownMW5152068
- ECT MACHINEFeb 27, 2024InjuryUnknownMW5152106
- ECT MACHINEFeb 7, 2024InjuryUnkMW5151178
- ECT THERAPYNov 14, 2023InjuryUnkMW5148153
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
2 firms currently registered for this product code
510(k) clearances
9 clearances for this product code
- Mecta CorporationApr 26, 2020
K192834 · MECTA Sigma
- Mecta Corp.Mar 6, 1997
K965070 · SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M.
- Mecta Corp.Sep 18, 1996
K960754 · SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M
- Somatics, Inc.Oct 26, 1995
K945120 · THYMATRON 2000 ELECTROCONVULSIVE SYSTEM
- Elcot, Inc.Oct 18, 1991
K911144 · MF-500, MODIFICATION
- Elcot, Inc.Jun 2, 1987
K863815 · ELECTROCONVULSIVE THERAPY DEVICE, MODEL MF-1000
- Medcraft Corp.Nov 10, 1986
K860467 · ELECTROSHOCK UNIT NEUROLOGY MODEL B-25
- Mecta Corp.Aug 9, 1985
K852069 · MECTA ECT DEVICE MODELS SR & JR