K192731 is an FDA 510(k) clearance for the ZIDA Wearable Neuromodulation System. This device is classified as a Stimulator, Peripheral Nerve, Non-implanted, For Urinary Incontinence (Class II - Special Controls, product code NAM).
Submitted by Exodus Innovations (Sufa, IL). The FDA issued a Cleared decision on March 19, 2021, 539 days after receiving the submission on September 27, 2019.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5310.
| 510(k) Number | K192731 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2019 |
| Decision Date | March 19, 2021 |
| Days to Decision | 539 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 |