510(k) · Cleared
ClearedElitone Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elidah, Inc. · QAJ Cutaneous Electrode Stimulator For Urinary Incontinence
Cleared on Feb 11, 2019 as substantially equivalent to DEN170049 (Bio-Medical Research, Ltd., 2018) after a 52-day review. Its family tree reaches back 1 generation to 2018. 2 later devices descend from it.
- Decided
- Feb 11, 2019
- Review
- 52 days
- Class
- Class II
- Product code
- QAJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170049 (2018). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backDEN170049 InnovoBio-Medical Research, Ltd. · 2018
- This deviceK183585 Elitone DeviceElidah, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK253285 Elitone for MenElidah, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK223884 ELITONE Urge Urinary Incontinence DeviceElidah, Inc. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN170049 | Innovo | Bio-Medical Research, Ltd. | 2018 | — |
| 0 (this device) | K183585 | Elitone Device | Elidah, Inc. | 2019 | — |
| +1 | K253285 | Elitone for Men | Elidah, Inc. | 2026 | — |
| +1 | K223884 | ELITONE Urge Urinary Incontinence Device | Elidah, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2026 | 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 QAJ? 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 QAJ device
- #1 K253285 Elitone for Menscore 11.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | DEN170049 | InnovoSummary page 4…Classification Product Code: QAJ Regulation Number: 876.5330 Classification: Class II Predicate Device: Innovo (DEN170049), manufactured by Bio-Medical Research Ltd. Device Description: The Elitone Device provides electrical muscle stimulation (commo… | 2018 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All QAJ devicesQAJ Cutaneous Electrode Stimulator For Urinary Incontinence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · QAJ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QAJ
Too few QAJ 510(k)s in any year since 2007 to give a median.
Recalls per year · QAJ
No recall names QAJ since 2007.
Adverse event reports per year · QAJ
1in 2024
MAUDE reports naming product code QAJ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 1 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
ELITONE is a non-implanted muscle stimulator designed to treat stress urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding tissues.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183585 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183585: Elitone Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183585
Report an extraction error
Are you the manufacturer?
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