510(k) · Cleared
ClearedStiwell MED4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Otto Bock, Austria GmbH · IPF Stimulator, Muscle, Powered
Cleared on Apr 2, 2009 as substantially equivalent to K032954 (Danmeter A/S, 2004) and 5 other predicates after a 364-day review. Its family tree reaches back 6 generations to 1995. 34 later devices descend from it.
- Decided
- Apr 2, 2009
- Review
- 364 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to K930530 (1995). 23 ancestors in all, the oldest K813008 (1981). 34 later devices descend from it, 8 citing it directly.
- Root · 6 generations backK930530 Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri IncHollister, Inc. · 1995
- 5 generations backK961872 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1996
- 4 generations backK974048 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1997
- 3 generations backK013612 Incare Pelvic Floor Therapy SystemHollister, Inc. · 2002
- 2 generations backK050483 Evadri Bladder Control SystemsHollister, Inc. · 2005
- 1 generation backK053434 Myotrac Infiniti Electrical StimulatorThought Technology, Ltd. · 2006
- This deviceK080950 Stiwell MED4Otto Bock, Austria GmbH · 2009
- Descendant · cites it directly · 21 of its ownK110179 IncontrolIncontrol Medical, LLC · 2012
- Descendant · 2 generations on · 10 of its ownK134020 IntonemvIncontrol Medical, LLC · 2014
- Descendant · 2 generations on · 9 of its ownK141158 APEXIncontrol Medical, LLC · 2014
- Descendant · 3 generations on · 6 of its ownK181497 HPM-6000UFBTL Industries, Inc. · 2018
- Descendant · 3 generations on · 4 of its ownK142506 TensCare KegelFitTenscare, Ltd. · 2015
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K110179IncontrolIncontrol Medical, LLC · 2012 · cites it directly21descendants
- K134020IntonemvIncontrol Medical, LLC · 2014 · 2 generations on10descendants
- K141158APEXIncontrol Medical, LLC · 2014 · 2 generations on9descendants
- K181497HPM-6000UFBTL Industries, Inc. · 2018 · 3 generations on6descendants
- K142506TensCare KegelFitTenscare, Ltd. · 2015 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K930530 | Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri Inc | Hollister, Inc. | 1995 | — |
| −5 | K961872 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1996 | — |
| −4 | K974048 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1997 | — |
| −3 | K013612 | Incare Pelvic Floor Therapy System | Hollister, Inc. | 2002 | — |
| −2 | K050483 | Evadri Bladder Control Systems | Hollister, Inc. | 2005 | — |
| −1 | K053434 | Myotrac Infiniti Electrical Stimulator | Thought Technology, Ltd. | 2006 | — |
| 0 (this device) | K080950 | Stiwell MED4 | Otto Bock, Austria GmbH | 2009 | — |
| +1 | K110179 | Incontrol | Incontrol Medical, LLC | 2012 | — |
| +2 | K134020 | Intonemv | Incontrol Medical, LLC | 2014 | — |
| +2 | K141158 | APEX | Incontrol Medical, LLC | 2014 | — |
| +3 | K181497 | HPM-6000UF | BTL Industries, Inc. | 2018 | — |
| +3 | K142506 | TensCare KegelFit | Tenscare, Ltd. | 2015 | — |
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 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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 IPF? 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 IPF device
- #1 K241433 EVE Synergy (EVE-20M)score 19.6 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K032954 | Elpha, Models II 500, II 1000, II 2000, II 3000 and E80Summary page 2…Product Clearance No. Number Code(s) Date K032954 Elpho Models II Danmeter A/S 890.5850 IPF, GZJ 08/09/2004… | 2004 |
| * | K053434 | Myotrac Infiniti Electrical StimulatorSummary page 2…nmeter A/S 890.5850 IPF, GZJ 08/09/2004 500,11 1000, II 2000,11 3000 A K053434 Myotrac Infinity Thought 876.5320 KPI, 03/15/2006… | 2006 |
| * | K040849 | MentamoveSummary page 2…6.5320 KPI, 03/15/2006 Electrical Stimulator Technology Ltd. HCC, IPF K040849 Mentamove Cole & 890,5850 IPF, HCC 10/01/2004… | 2004 |
| * | K940301 | Compex 2Summary page 2…Cole & 890,5850 IPF, HCC 10/01/2004 Associates K940301 Compex 2 Biodex Medical 890.5850 IPF, GZJ 12/28/1994… | 1994 |
| * | K032988 | Elpha 4 ContiSummary page 2…890.5850 IPF, GZJ 12/28/1994 ____ ____ ____ ____ ____ ___ Systems, Inc. K032988 Elpha 4 Conti Donmeter A/S 876.5320 KPI 12/03/2003 K03190… | 2003 |
| * | K031900 | HandmasterSummary page 2…__ ___ Systems, Inc. K032988 Elpha 4 Conti Donmeter A/S 876.5320 KPI 12/03/2003 K031900 Handmaster Ness- 882.5810 GZI 08/08/2003… | 2003 |
What descends from it? (34)
See all 348 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110179 | Incontrol | 2012 | 21 |
| K202648 | Biofeedback Nerve and Muscle Stimulator | 2020 | 2 |
| K201290 | Medline DeNovo 4Pro Electrical Stimulation Device | 2020 | 2 |
| K210002 | Stella Bio | 2021 | 1 |
| K243828 | Cionic Neural Sleeve (NS-200) | 2025 | 0 |
| K232786 | Stimulation System (PA series, PR series, S series and Q series) | 2024 | 0 |
| K230701 | Stim2Go | 2023 | 0 |
| K200088 | g.Estim FES | 2020 | 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 14 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 23 ancestors has a recall.
- Of its descendants, K110179 (Incontrol Medical, LLC, 2012) has gone furthest, with 21 descendants of its own.
- 2 other devices also cite its predicate K032954.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · IPF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IPF
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IPF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IPF
8in 2025
MAUDE reports naming product code IPF, 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 | 8 | 143 | 0 | 11 |
| 2008 | 6 | 140 | 1 | 213 |
| 2009 | 7 | 216 | 0 | 150 |
| 2010 | 4 | 121 | 0 | 14 |
| 2011 | 4 | 275 | 1 | 25 |
| 2012 | 4 | 269 | 3 | 16 |
| 2013 | 10 | 180 | 0 | 6 |
| 2014 | 4 | 264 | 0 | 19 |
| 2015 | 3 | 43 | 0 | 11 |
| 2016 | 7 | 113 | 0 | 8 |
| 2017 | 5 | 110 | 0 | 2 |
| 2018 | 5 | 73 | 0 | 3 |
| 2019 | 4 | 133 | 0 | 10 |
| 2020 | 9 | 121 | 0 | 13 |
| 2021 | 15 | 98 | 0 | 3 |
| 2022 | 7 | 108 | 0 | 4 |
| 2023 | 9 | 255 | 1 | 8 |
| 2024 | 7 | 201 | 0 | 5 |
| 2025 | 3 | 257 | 0 | 8 |
| 2026 | 3 | 206 | 0 | — |
What is it indicated for?
The STIWELL med4 is a neuromuscular electronic stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. As a powered muscle stimulator the STIWELL med4 is indicated for the following conditions: * Relaxation of muscle spasm * Prevention or retardation of disuse atrophy * Increasing local blood circulation * Muscle re-education * Immediate post-surgical stimulation of calf muscles…
Read the full statement (235 words)
The STIWELL med4 is a neuromuscular electronic stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions.
As a powered muscle stimulator the STIWELL med4 is indicated for the following conditions:
* Relaxation of muscle spasm
* Prevention or retardation of disuse atrophy
* Increasing local blood circulation
* Muscle re-education
* Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
* Maintaining or increasing range of motion
As a transcutaneous electrical nerve stimulator for pain relief the STIWELL med4 is indicated for the following conditions:
* Symptomatic relief and management of chronic (long-term), intractable pain
* Adjunctive treatment inthe management of post-surgical pain and post traumatic acute pain
As a biofeedback device the STIWELL med4 is indicated for the following conditions:
* Biofeedback, relaxation and muscle re-education purposes
As an external functional neuromuscular stimulator the STIWELL med4 is indicated for the following conditions:
: Helps to relearn voluntary motor functions of the extremities
As a nonimplanted electrical continence device the STIWELL med4 is indicated for the following conditions:
- Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the
following results may improve urinary control: Inhibition of the detruser muscles through reflexive
mechanisms and strengthening of pelvic floor muscles
* Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles
such as the abdominal and the gluteus muscles
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/K080950 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080950: Stiwell MED4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080950
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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