Device, Electroconvulsive Therapy

Product Code: GXC

Neurology Microwave Medical Products

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 882.5940


Radiation TypeMicrowave EMF
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as GXC

3655Device, Electroconvulsive TherapyElectroconvulsive Therapy Device.

Total Product Life Cycle (TPLC) Devices

3655Device, Electroconvulsive TherapyElectroconvulsive Therapy Device.

Pre-market Notifications for GXC

K965070SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M.MECTA CORP.
K960754SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 MMECTA CORP.
K945120THYMATRON 2000 ELECTROCONVULSIVE SYSTEMSOMATICS, INC.
K911144MF-500, MODIFICATIONELCOT, INC.
K863815ELECTROCONVULSIVE THERAPY DEVICE, MODEL MF-1000ELCOT, INC.
K852069MECTA ECT DEVICE MODELS SR & JRMECTA CORP.
K843923THYMATRONSOMATICS, INC.

Global Unique Device Identification Database

10607915110755Device, Electroconvulsive Therapy
00861539000134Device, Electroconvulsive Therapy
00861539000127Device, Electroconvulsive Therapy
00861539000110Device, Electroconvulsive Therapy
00861539000103Device, Electroconvulsive Therapy
00850298007003Device, Electroconvulsive Therapy

Maude Adverse Events

THYMATRONSOMATICS LLC.2020-03-31
SOMATICS THYMATRONSOMATICS LLC2020-03-26
SOMATICS THYMATRON SYSTEM IVSOMATICS LLC2020-03-25
MECTA SPECTRUMMECTA CORPORATION2020-03-25
MECTA SR2MECTA CORPORATION2020-03-24
ELECTROCONVULSIVE THERAPY DEVICE THYMATRON SYSTEM IVSOMATICS, LLC2020-03-24
THYMATRON IVSOMATICS, LLC2020-03-17
ECTDEVICE, ELECTROCONVULSIVE THERAPYUNK2020-03-16
THYMATRONSOMATICS, LLC2020-02-25
THYMATRONSOMATICS, LLC2020-02-25
ELECTRIC SHOCK TREATMENT MACHINESOMATICS LLC2020-01-27
SOMATICS, LLCSOMATICS, LLC2020-01-22
ELECTROSHOCK THERAPY MACHINEUNK2019-11-26
SPECTRUMMECTA CORPORATION2019-11-25
ECTDEVICE, ELECTROCONVULSIVE THERAPYUNK2019-11-12
ECTDEVICE, ELECTROCONVULSIVE THERAPYUNK2019-11-12
ECTDEVICE, ELECTROCONVULSIVE THERAPYUNK2019-11-12
ECTDEVICE, ELECTROCONVULSIVE THERAPYUNK2019-11-12
ECTDEVICE, ELECTROCONVULSIVE THERAPYUNK2019-11-12
ECTDEVICE, ELECTROCONVULSIVE THERAPYUNK2019-11-12
ECTDEVICE, ELECTROCONVULSIVE THERAPYUNK2019-11-12
ECTDEVICE, ELECTROCONVULSIVE THERAPYUNK2019-11-12
ECTDEVICE, ELECTROCONVULSIVE THERAPYUNK2019-11-12
SPECTRUMMECTA CORPORATION2019-10-31
SPECTRUMMECTA CORPORATION2019-10-31
ELECTROCONVULSIVE THERAPYUNK2019-09-03
ECTDEVICE, ELECTROCONVULSIVE THERAPYUNKNOWN2019-07-02
ECT MACHINEUNK2019-06-26
ECT MACHINEUNK2019-06-18
ELECTROCONVULSIVE TREATMENT MACHINEUNK2019-06-18
ELECTROCONVULSIVE TREATMENT MACHINEUNK2019-05-09
ELECTROCONVULSIVE TREATMENT MACHINEUNK2019-05-09
SOMATICS, LLCSOMATICS, LLC2019-04-24
SOMATICS AND MECTA CORPORATIONSOMATICS, LLC2019-03-22
MECTA CORPORATION2019-03-22
THYMATRON BY SOMATICSSOMATICS, LLC2019-03-20
ECTDEVICEMECTA CORPORATION2019-03-20
THYMATRON BY SOMATICSSOMATICS, LLC2019-03-20
MECTA ECT INSTRUMENTMECTA CORPORATION2019-03-18
MECTA ECT INSTRUMENTMECTA CORPORATION2019-03-18
ECT MACHINEMECTA CORP.2018-12-19
ELECTROCONVULSIVE THERAPY MACHINEMECTA CORPORATION / SOMATICS LLC2018-11-20
ELECTROCONVULSIVE THERAPY MACHINEMECTA CORPORATION2018-11-20
ELECTROCONVULSIVE THERAPY MACHINESOMATICS LLC2018-11-20
ECT DEVICEMECTA CORPORATION2018-02-23
MECTAMECTA CORPORATION2018-02-23
MECTAMECTA CORPORATION2018-02-23
MECTA SPECTRUM 5000QMECTA CORPORATION2018-02-23
MECTA SPECTRUM 5000QMECTA CORPORATION2018-02-23
MECTA SPECTRUM 5000QMECTA CORPORATION2018-02-23
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