510(k) · Cleared
ClearedVivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avation Medical, Inc. · NAM Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence
Cleared on Apr 3, 2023 as substantially equivalent to K192731 (Exodus Innovations, 2021) after a 410-day review. Its family tree reaches back 4 generations to 2005.
- Decided
- Apr 3, 2023
- Review
- 410 days
- Class
- Class II
- Product code
- NAM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K052025 (2005). No later device cites it as a predicate yet.
- Root · 4 generations backK052025 Urgent PC Neuromodulation SystemUroplasty, Inc. · 2005
- 3 generations backK061333 Urgent PC Neuromodulation System, Models UPC200-a and UPC250-12Uroplasty, Inc. · 2006
- 2 generations backK071822 Urgent PC Neuromodulation System, Models UPC200 and UPC250-12Uroplasty, Inc. · 2007
- 1 generation backK192731 ZIDA Wearable Neuromodulation SystemExodus Innovations · 2021
- This deviceK220454 Vivally System Wearable, Non-Invasive Neuromodulation System and…Avation Medical, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K052025 | Urgent PC Neuromodulation System | Uroplasty, Inc. | 2005 | — |
| −3 | K061333 | Urgent PC Neuromodulation System, Models UPC200-a and UPC250-12 | Uroplasty, Inc. | 2006 | — |
| −2 | K071822 | Urgent PC Neuromodulation System, Models UPC200 and UPC250-12 | Uroplasty, Inc. | 2007 | — |
| −1 | K192731 | ZIDA Wearable Neuromodulation System | Exodus Innovations | 2021 | — |
| 0 (this device) | K220454 | Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile… | Avation Medical, Inc. | 2023 | — |
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 K192731 ZIDA Wearable Neuromodulation Systemscore 4.6 · 3 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.
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- None of the 4 ancestors has a recall.
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. 2023, 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?
The Vivally® System is a wearable neuromodulation system to treat patients with the bladder conditions of urge urinary incontinence and urinary urgency.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220454 · printed Nov 4, 2026
Cite this page
510(k) Report. “K220454: Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K220454
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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