K250451 is an FDA 510(k) clearance for the NeurAxis IB-Stim (01-1020). This device is classified as a Non-implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (ibs) (Class II - Special Controls, product code QHH).
Submitted by Neuraxis (Carmel, US). The FDA issued a Cleared decision on May 15, 2025, 86 days after receiving the submission on February 18, 2025.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 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..
| 510(k) Number | K250451 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 2025 |
| Decision Date | May 15, 2025 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | QHH - Non-implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (ibs) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5340 |
| 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. |