510(k) K220454 ยท NAM Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence
Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application
| Applicant | Avation Medical, Inc., Columbus OH, US |
| Decision | Substantially Equivalent, Apr 3, 2023 |
| Received | Feb 17, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220454
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.