QHH — Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs) Class II
FDA product code QHH covers "Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)", a Class II medical device regulated under 21 CFR 876.5340. Submissions are reviewed by the Gastroenterology, Urology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QHH
- Device Class
- Class II
- Regulation Number
- 876.5340
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252024 | neuraxis | NeurAxis IB-Stim (01-1020) | October 16, 2025 |
| K250451 | neuraxis | NeurAxis IB-Stim (01-1020) | May 15, 2025 |
| K241533 | neuraxis | NeurAxis IB-Stim (01-1020) | October 30, 2024 |
| K230526 | transtimulation research | TEA Device | September 14, 2023 |
| K202940 | dyansys | First Relief v1 | December 29, 2020 |
| DEN180057 | innovative health solutions (ihs) | IB-Stim | June 7, 2019 |