QHH

Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)

Product code

QHH

Device name

Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)

Device class

Class 2

21 CFR

21 CFR 876.5340

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

4

Summaries archived here

4 (direct download)

510(k) clearances (all years, FDA)

6 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (4)

Last three years. Most recent: 2025-10-16.

4 summaries are archived here for direct download.