K220454 is an FDA 510(k) clearance for the Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application. This device is classified as a Stimulator, Peripheral Nerve, Non-implanted, For Urinary Incontinence (Class II - Special Controls, product code NAM).
Submitted by Avation Medical, Inc. (Columbus, US). The FDA issued a Cleared decision on April 3, 2023, 410 days after receiving the submission on February 17, 2022.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5310.
| 510(k) Number | K220454 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 17, 2022 |
| Decision Date | April 03, 2023 |
| Days to Decision | 410 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | NAM - Stimulator, Peripheral Nerve, Non-implanted, For Urinary Incontinence |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5310 |