Panels › Gastroenterology, Urology › Product code QHH · Class 2
Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)
Regulation 876.5340
0510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QHH
| Company | 510(k)s | Recalls |
|---|---|---|
| Neuraxis | 3 | 0 |
| Dyansys, Inc. | 1 | 0 |
| Innovative Health Solutions (Ihs), Inc. | 1 | 0 |
| Transtimulation Research, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 16, 2025 | K252024 | NeurAxis IB-Stim (01-1020) Neuraxis | QHH |
| May 15, 2025 | K250451 | NeurAxis IB-Stim (01-1020) Neuraxis | QHH |
| Oct 30, 2024 | K241533 | NeurAxis IB-Stim (01-1020) Neuraxis | QHH |
| Sep 14, 2023 | K230526 | TEA Device Transtimulation Research, Inc. | QHH |
| Dec 29, 2020 | K202940 | First Relief v1 Dyansys, Inc. | QHH |
| Jun 7, 2019 | DEN180057 | IB-Stim Innovative Health Solutions (Ihs), Inc. | QHH |
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