K230526 is an FDA 510(k) clearance for the TEA Device. 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 Transtimulation Research, Inc. (Oklahoma City, US). The FDA issued a Cleared decision on September 14, 2023, 199 days after receiving the submission on February 27, 2023.
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 | K230526 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 2023 |
| Decision Date | September 14, 2023 |
| Days to Decision | 199 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. |