GXCClass III
Device, Electroconvulsive Therapy
Neurology · 21 CFR 882.5940
MDR events303All time
Recalls0All time
Registered firms1Currently listed
510(k) clearances0All time
Recent MDR events
303 adverse event reports on file
- ECT DEVICEMay 18, 2026DeathMecta Corp.3010023564-2026-00001
- ECT DEVICEApr 30, 2026DeathSigmastim Domestic Llc.MW5187489
- ECT MACHINEMar 24, 2026InjuryUnknownMW5185631
- DEVICE, ELECTROCONVULSIVE THERAPYAug 1, 2025InjuryUnknownMW5173761
- ELECTROCONVULSIVE THERAPY (ALSO KNOWN AS ELECTROSHOCK THERAPY)Jul 3, 2025InjuryUnknownMW5172224
- ECT TREATMENTJun 26, 2025InjuryUnknownMW5172068
- ECT MACHINE DEVICEFeb 18, 2025InjuryUnknownMW5166331
- ECT MACHINEFeb 13, 2025InjuryUnknownMW5166169
- ELECTROCONVULSIVE THERAPY MACHINEJan 6, 2025InjuryUnknownMW5164363
- ECT MACHINEJan 2, 2025InjuryUnknownMW5164212
Event type breakdown
Injury251
Malfunction17
Death14
Other14
Unspecified7
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
1 firms currently registered for this product code
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.