QHHClass II
Non-implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (ibs)
Gastroenterology, Urology · 21 CFR 876.5340
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.
MDR events3All time
Recalls0All time
Registered firms6Currently listed
510(k) clearances6All time
Recent MDR events
3 adverse event reports on file
Event type breakdown
Injury3
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
6 firms currently registered for this product code
510(k) clearances
6 clearances for this product code
- NeuraxisOct 16, 2025
K252024 · NeurAxis IB-Stim (01-1020)
- NeuraxisMay 15, 2025
K250451 · NeurAxis IB-Stim (01-1020)
- NeuraxisOct 30, 2024
K241533 · NeurAxis IB-Stim (01-1020)
- Transtimulation Research, Inc.Sep 14, 2023
K230526 · TEA Device
- Dyansys, Inc.Dec 29, 2020
K202940 · First Relief v1
- Innovative Health Solutions (Ihs), Inc.Jun 7, 2019
DEN180057 · IB-Stim