Device, Electroconvulsive Therapy

Device Code: 3655

Product Code(s): GXC

Device Classification Information

• Device Type ID: 3655
• Device Name: Device, Electroconvulsive Therapy
• Regulation Description: Electroconvulsive Therapy Device.
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Neurological And Physical Medicine Devices (DNPMD); Neurostimulation Devices Psychiatry Branch (NSDP)
• Submission Type: 510(k)
• CFR Regulation Number: 882.5940 [🔎]
• FDA Device Classification: Class 3 Medical Device
• Product Code: GXC
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 3655
• Device: Device, Electroconvulsive Therapy
• Product Code: GXC
• FDA Device Classification: Class 3 Medical Device
• Regulation Description: Electroconvulsive Therapy Device.
• CFR Regulation Number: 882.5940 [🔎]

Device Problems
Device Operational Issue	2
Total Device Problems	2

TPLC Last Update: 2019-04-02 20:33:53