FDA Product Code QGT: Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
A Trunk And Limb Electrical Stimulator To Treat Headache Is A Device Intended To Treat Headache Through The Application Of Electrical Stimulation Anywhere On The Body Of The Patient Apart From The Patient's Head Or Neck Through Electrodes Placed On The Skin. The Stimulation May Be Provided Transcutaneously Or Percutaneously.
Leading manufacturers include Theranica Bioelectronics , Ltd. and Theranica Bio-Electronics, Ltd..
FDA 510(k) Cleared Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine Devices (Product Code QGT)
About Product Code QGT - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code QGT since 2019, with 6 receiving FDA clearance (average review time: 118 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA Review Time
Recent submissions under QGT have taken an average of 101 days to reach a decision - down from 125 days historically, suggesting improved FDA processing for this classification.
QGT devices are reviewed by the Neurology panel. Browse all Neurology devices →