# Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)
> **Product code: QHH** · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.5340
## Classification
- **FDA Product Code:** QHH
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 876.5340
- **Review panel:** GU
- **Medical specialty:** Gastroenterology, Urology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 6
- **Registered establishments:** 5
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QHH)
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