K202940 is an FDA 510(k) clearance for the First Relief v1. 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 Dyansys, Inc. (San Mateo, US). The FDA issued a Cleared decision on December 29, 2020, 90 days after receiving the submission on September 30, 2020.
This device falls under the Neurology 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 | K202940 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2020 |
| Decision Date | December 29, 2020 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| 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. |