510(k) · Cleared
ClearedTenscare Itouch Sure Model Its
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tenscare, Ltd. · KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Cleared on Jun 21, 2011 as substantially equivalent to K941911 (Empi, 1995) after a 183-day review. Its family tree reaches back 1 generation to 1995. 6 later devices descend from it.
- Decided
- Jun 21, 2011
- Review
- 183 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K941911 (1995). 6 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK941911 Innova Pelvic Floor Stimulation SystemEmpi · 1995
- This deviceK103698 Tenscare Itouch Sure Model ItsTenscare, Ltd. · 2011
- Descendant · cites it directly · 4 of its ownK142506 TensCare KegelFitTenscare, Ltd. · 2015
- Descendant · 2 generations on · 3 of its ownK191312 Perfect PFETenscare, Ltd. · 2019
- Descendant · 3 generations on · 0 of its ownK260178 Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK251760 Well-Life Incontinence Stimulation System (WL-2405i (P))Well-Life Healthcare, Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK230983 Unicare (K-UNICARE-USA)Tenscare, Ltd. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K142506TensCare KegelFitTenscare, Ltd. · 2015 · cites it directly4descendants
- K191312Perfect PFETenscare, Ltd. · 2019 · 2 generations on3descendants
- K260178Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd. · 2026 · 3 generations on0descendants
- K251760Well-Life Incontinence Stimulation System (WL-2405i (P))Well-Life Healthcare, Ltd. · 2026 · 3 generations on0descendants
- K230983Unicare (K-UNICARE-USA)Tenscare, Ltd. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941911 | Innova Pelvic Floor Stimulation System | Empi | 1995 | — |
| 0 (this device) | K103698 | Tenscare Itouch Sure Model Its | Tenscare, Ltd. | 2011 | — |
| +1 | K142506 | TensCare KegelFit | Tenscare, Ltd. | 2015 | — |
| +2 | K191312 | Perfect PFE | Tenscare, Ltd. | 2019 | — |
| +3 | K260178 | Pelvic Muscle Trainer (KM510, KM516B) | Shenzhen Konmed Technology Co., Ltd. | 2026 | — |
| +3 | K251760 | Well-Life Incontinence Stimulation System (WL-2405i (P)) | Well-Life Healthcare, Ltd. | 2026 | — |
| +3 | K230983 | Unicare (K-UNICARE-USA) | Tenscare, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 2 | 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 KPI? 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 KPI device
- #1 K262353 BTL-299-Fscore 14.8 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K941911 | Innova Pelvic Floor Stimulation SystemSummary page 1…Title 21, Code of Federal Regulations Sec.876.5320 ProCodle: 78 KPI Device Classification: Class 11 Predicate Devices: Innova Pelvic Floor Stimulation System by EMPI. K941911 Kegel 8 Pelvic Muscle Trainer by NE Services. K81480 The class of the predicate Devices: Class 11 Device D… | 1995 |
| Kept off the family tree | K81480 | Kegel 8 Pelvic Muscle Trainer Number could not be read Summary page 1…e Classification: Class 11 Predicate Devices: Innova Pelvic Floor Stimulation System by EMPI. K941911 Kegel 8 Pelvic Muscle Trainer by NE Services. K81480 The class of the predicate Devices: Class 11 Device Description: The itouch Sure is a small lightweight battery powered single c… |
What descends from it? (6)
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 KPI devicesKPI Stimulator, Electrical, Non-Implantable, For Incontinence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · KPI
7so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · KPI
263in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPI
No recall names KPI since 2007.
Adverse event reports per year · KPI
2in 2024
MAUDE reports naming product code KPI, 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 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 3 | 57 | 0 | 0 |
| 2015 | 6 | 260 | 0 | 2 |
| 2016 | 3 | 89 | 0 | 0 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 3 | 304 | 0 | 0 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 3 | 217 | 0 | 1 |
| 2022 | 3 | 181 | 0 | 2 |
| 2023 | 3 | 197 | 0 | 6 |
| 2024 | 4 | 172 | 0 | 2 |
| 2025 | 4 | 263 | 0 | 0 |
| 2026 | 7 | 248 | 0 | — |
What is it indicated for?
The itouch Sure is intended to provide electrical stimulation and neuromuscular re-education
for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge,
and mixed urinary incontinence in women
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103698 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103698: Tenscare Itouch Sure Model Its.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103698
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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