FDA Product Code QHH: Non-implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (ibs)
A Non-implanted Nerve Stimulator For Functional Abdominal Pain Relief Is A Device That Stimulates Nerves Remotely From The Source Of Pain With The Intent To Relieve Functional Abdominal Pain. This Generic Type Of Device Does Not Include Devices Designed To Relieve Pelvic Pain.
Leading manufacturers include Neuraxis and Transtimulation Research, Inc..
FDA 510(k) Cleared Non-implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (ibs) Devices (Product Code QHH)
About Product Code QHH - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code QHH since 2019, with 5 receiving FDA clearance (average review time: 144 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under QHH have taken an average of 116 days to reach a decision - down from 171 days historically, suggesting improved FDA processing for this classification.
QHH devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →