K241533 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 October 30, 2024, 153 days after receiving the submission on May 30, 2024.
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 | K241533 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 2024 |
| Decision Date | October 30, 2024 |
| Days to Decision | 153 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. |