510(k) · Cleared
ClearedZIDA Wearable Neuromodulation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exodus Innovations · NAM Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence
Cleared on Mar 19, 2021 as substantially equivalent to K071822 (Uroplasty, Inc., 2007) after a 539-day review. Its family tree reaches back 3 generations to 2005. 1 later device descends from it.
- Decided
- Mar 19, 2021
- Review
- 539 days
- Class
- Class II
- Product code
- NAM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K052025 (2005). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK052025 Urgent PC Neuromodulation SystemUroplasty, Inc. · 2005
- 2 generations backK061333 Urgent PC Neuromodulation System, Models UPC200-a and UPC250-12Uroplasty, Inc. · 2006
- 1 generation backK071822 Urgent PC Neuromodulation System, Models UPC200 and UPC250-12Uroplasty, Inc. · 2007
- This deviceK192731 ZIDA Wearable Neuromodulation SystemExodus Innovations · 2021
- Descendant · cites it directly · 0 of its ownK220454 Vivally System Wearable, Non-Invasive Neuromodulation System and…Avation Medical, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K220454Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile ApplicationAvation Medical, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K052025 | Urgent PC Neuromodulation System | Uroplasty, Inc. | 2005 | — |
| −2 | K061333 | Urgent PC Neuromodulation System, Models UPC200-a and UPC250-12 | Uroplasty, Inc. | 2006 | — |
| −1 | K071822 | Urgent PC Neuromodulation System, Models UPC200 and UPC250-12 | Uroplasty, Inc. | 2007 | — |
| 0 (this device) | K192731 | ZIDA Wearable Neuromodulation System | Exodus Innovations | 2021 | — |
| +1 | K220454 | Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile… | Avation Medical, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NAM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NAM device
- #1 K220454 Vivally System Wearable, Non-Invasive…score 6.0 · 4 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071822 | Urgent PC Neuromodulation System, Models UPC200 and UPC250-12Summary page 4…tion: 876.5310 Nonimplanted, peripheral electrical continence device. Product Codes: NAM Predicate Device: Urgent PC Neuromodulation System, K071822, NAM Device Description: ZIDA Wearable Neuromodulation System (ZIDA System) is a home-use system that is a neuromodulation sy… | 2007 |
| † | K090889 | Emsi Garment Electrodes | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220454 | Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K220454 (Avation Medical, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K071822.
How does its category compare?
All NAM devicesNAM Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · NAM
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NAM
Too few NAM 510(k)s in any year since 2007 to give a median.
Recalls per year · NAM
No recall names NAM since 2007.
Adverse event reports per year · NAM
3in 2023
MAUDE reports naming product code NAM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 26 |
| 2017 | 0 | — | 0 | 52 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K192731 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192731: ZIDA Wearable Neuromodulation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192731
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026