# K220454: Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application

- Pathway: 510(k) (Traditional)
- Applicant: Avation Medical, Inc.
- Decided: Apr 3, 2023 after 410 days
- Product code: NAM (Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence)
- Device class: 2
- Regulation: 21 CFR 876.5310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K052025 (2005). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192731: ZIDA Wearable Neuromodulation System, Exodus Innovations (2021) Summary page 4.

## Indications for use
The Vivally® System is a wearable neuromodulation system to treat patients with the bladder conditions of urge urinary incontinence and urinary urgency.

Source page: https://510kreport.com/device/K220454
Methodology: https://510kreport.com/methodology