510(k) · Cleared
ClearedTensCare KegelFit
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 Apr 20, 2015 as substantially equivalent to K141158 (Incontrol Medical, LLC, 2014) and 1 other predicate after a 224-day review. Its family tree reaches back 9 generations to 1995. 4 later devices descend from it.
- Decided
- Apr 20, 2015
- Review
- 224 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K930530 (1995). 28 ancestors in all, the oldest K813008 (1981). 4 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK930530 Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri IncHollister, Inc. · 1995
- 5 generations between
- 3 generations backK080950 Stiwell MED4Otto Bock, Austria GmbH · 2009
- 2 generations backK110179 IncontrolIncontrol Medical, LLC · 2012
- 1 generation backK141158 APEXIncontrol Medical, LLC · 2014
- This deviceK142506 TensCare KegelFitTenscare, Ltd. · 2015
- Descendant · cites it directly · 3 of its ownK191312 Perfect PFETenscare, Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK260178 Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK251760 Well-Life Incontinence Stimulation System (WL-2405i (P))Well-Life Healthcare, Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK230983 Unicare (K-UNICARE-USA)Tenscare, Ltd. · 2023
Show all 9 generations
- Root · 9 generations backK930530 Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri IncHollister, Inc. · 1995
- 8 generations backK961872 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1996
- 7 generations backK974048 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1997
- 6 generations backK013612 Incare Pelvic Floor Therapy SystemHollister, Inc. · 2002
- 5 generations backK050483 Evadri Bladder Control SystemsHollister, Inc. · 2005
- 4 generations backK053434 Myotrac Infiniti Electrical StimulatorThought Technology, Ltd. · 2006
- 3 generations backK080950 Stiwell MED4Otto Bock, Austria GmbH · 2009
- 2 generations backK110179 IncontrolIncontrol Medical, LLC · 2012
- 1 generation backK141158 APEXIncontrol Medical, LLC · 2014
- This deviceK142506 TensCare KegelFitTenscare, Ltd. · 2015
Most influential descendants
Showing 4 of 4 · See all- K191312Perfect PFETenscare, Ltd. · 2019 · cites it directly3descendants
- K260178Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd. · 2026 · 2 generations on0descendants
- K251760Well-Life Incontinence Stimulation System (WL-2405i (P))Well-Life Healthcare, Ltd. · 2026 · 2 generations on0descendants
- K230983Unicare (K-UNICARE-USA)Tenscare, Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K930530 | Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri Inc | Hollister, Inc. | 1995 | — |
| −8 | K961872 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1996 | — |
| −7 | K974048 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1997 | — |
| −6 | K013612 | Incare Pelvic Floor Therapy System | Hollister, Inc. | 2002 | — |
| −5 | K050483 | Evadri Bladder Control Systems | Hollister, Inc. | 2005 | — |
| −4 | K053434 | Myotrac Infiniti Electrical Stimulator | Thought Technology, Ltd. | 2006 | — |
| −3 | K080950 | Stiwell MED4 | Otto Bock, Austria GmbH | 2009 | — |
| −2 | K110179 | Incontrol | Incontrol Medical, LLC | 2012 | — |
| −1 | K141158 | APEX | Incontrol Medical, LLC | 2014 | — |
| 0 (this device) | K142506 | TensCare KegelFit | Tenscare, Ltd. | 2015 | — |
| +1 | K191312 | Perfect PFE | Tenscare, Ltd. | 2019 | — |
| +2 | K260178 | Pelvic Muscle Trainer (KM510, KM516B) | Shenzhen Konmed Technology Co., Ltd. | 2026 | — |
| +2 | K251760 | Well-Life Incontinence Stimulation System (WL-2405i (P)) | Well-Life Healthcare, Ltd. | 2026 | — |
| +2 | K230983 | Unicare (K-UNICARE-USA) | Tenscare, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K141158 | APEX Cleared while this submission was under review Summary page 5…Pg. 2 of 11 III Predicate Devices: 510(k) Name Product Class Use Manufacturer Code Primary Predicate K141158 Apex KPI II OTC InControl Medical, LLC… | 2014 |
| * | K103698 | Tenscare Itouch Sure Model ItsSummary page 5…3225 Gateway Road, Ste. 250 Brookfield, WI 53045 USA Secondary Predicate K103698 itouch Sure KPI II Prescription Tenscare Ltd Pelvic… | 2011 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191312 | Perfect PFE | 2019 | 3 |
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 20 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- None of the 28 ancestors has a recall.
- Of its descendants, K191312 (Tenscare, Ltd., 2019) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K141158.
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. 2015, 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?
KegelFit is a non-implanted muscle stimulator designed to treat female stress urinary incontinence.
It applies stimulation to the pelvic floor muscles to improve strength and support.
The KegelFit is intended for OTC sale.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142506 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142506: TensCare KegelFit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142506
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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