DeviceClearance

Product code QHH— Gastroenterology, Urology

NeurAxis IB-Stim (01-1020)

Classification name
Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)
Device class
Class 2
Regulation
21 CFR 876.5340
Advisory panel
Gastroenterology, Urology
Total cleared
6
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code QHH under 21 CFR 876.5340, via openFDA

Market context for product code QHH

FDA has cleared 6 devices under product code QHH between 2019 and 2025, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QHH

Recent clearances under product code QHH

Data sourced from openFDA. This site is unofficial and independent of the FDA.