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

- Device class: 2; regulation: 21 CFR 876.5340; FDA's rule: 510(k) required
- FDA decisions: 6
- 510(k) review time 2021–2025: median 131 days (middle half 103–165)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2019: 1
- 2020: 1
- 2023: 1
- 2024: 1
- 2025: 2

## Most-cited predicates
- DEN180057: IB-Stim (2019), cited by 3
- K250451: NeurAxis IB-Stim (01-1020) (2025), cited by 1
- K241533: NeurAxis IB-Stim (01-1020) (2024), cited by 1

Source page: https://510kreport.com/product-code/QHH
Data by year (CSV): https://510kreport.com/product-code/QHH.csv