# K192731: ZIDA Wearable Neuromodulation System

- Pathway: 510(k) (Traditional)
- Applicant: Exodus Innovations
- Decided: Mar 19, 2021 after 539 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: 3 generations back to K052025 (2005). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071822: Urgent PC Neuromodulation System, Models UPC200 and UPC250-12, Uroplasty, Inc. (2007) Summary page 4.

## Most influential descendants
- K220454: Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application (2023), 0 descendants of its own

## Indications for use
ZIDA Wearable Neuromodulation System is a neuromodulation system that is intended to treat patients with an overactive bladder (OAB) and associated symptoms of urinary urgency, urinary frequency, and urge incontinence.

Source page: https://510kreport.com/device/K192731
Methodology: https://510kreport.com/methodology