510(k) · Cleared
ClearedBiofeedback Nerve and Muscle Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Konmed Technology Co., Ltd. · IPF Stimulator, Muscle, Powered
Cleared on Dec 8, 2020 as substantially equivalent to K080950 (Otto Bock, Austria GmbH, 2009) after an 88-day review. Its family tree reaches back 7 generations to 1995. 2 later devices descend from it.
- Decided
- Dec 8, 2020
- Review
- 88 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K930530 (1995). 24 ancestors in all, the oldest K813008 (1981). 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK930530 Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri IncHollister, Inc. · 1995
- 6 generations backK961872 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1996
- 5 generations backK974048 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1997
- 4 generations backK013612 Incare Pelvic Floor Therapy SystemHollister, Inc. · 2002
- 3 generations backK050483 Evadri Bladder Control SystemsHollister, Inc. · 2005
- 2 generations backK053434 Myotrac Infiniti Electrical StimulatorThought Technology, Ltd. · 2006
- 1 generation backK080950 Stiwell MED4Otto Bock, Austria GmbH · 2009
- This deviceK202648 Biofeedback Nerve and Muscle StimulatorShenzhen Konmed Technology Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK222201 Biological Feedback and Stimulation SystemMedlander Medical Technology, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK220161 Biofeedback Nerve and Muscle StimulatorShenzhen Konmed Technology Co., Ltd. · 2022
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 |
|---|---|---|---|---|---|
| −7 | K930530 | Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri Inc | Hollister, Inc. | 1995 | — |
| −6 | K961872 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1996 | — |
| −5 | K974048 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1997 | — |
| −4 | K013612 | Incare Pelvic Floor Therapy System | Hollister, Inc. | 2002 | — |
| −3 | K050483 | Evadri Bladder Control Systems | Hollister, Inc. | 2005 | — |
| −2 | K053434 | Myotrac Infiniti Electrical Stimulator | Thought Technology, Ltd. | 2006 | — |
| −1 | K080950 | Stiwell MED4 | Otto Bock, Austria GmbH | 2009 | — |
| 0 (this device) | K202648 | Biofeedback Nerve and Muscle Stimulator | Shenzhen Konmed Technology Co., Ltd. | 2020 | — |
| +1 | K222201 | Biological Feedback and Stimulation System | Medlander Medical Technology, Inc. | 2022 | — |
| +1 | K220161 | Biofeedback Nerve and Muscle Stimulator | Shenzhen Konmed Technology Co., Ltd. | 2022 | — |
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 |
|---|---|---|
| 2022 | 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 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 19.7 · 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? (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 |
|---|---|---|---|
| * | K080950 | Stiwell MED4Summary page 5…henzhen Konmed Technology Co., Ltd. 510(k)s – 510 (k) Summary Device Name and Model STIWELL med4/ Model: 900101S 510(k) Number K080950 Product Code IPF, GZI, KPI, GZJ, HCC 21 CFR 890.5850… | 2009 |
| † | K053434 | Myotrac Infiniti Electrical Stimulator | 2006 |
| † | K081480 | KEGEL8 Pelvic Exerciser, Model Oph 400 | 2008 |
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?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- None of the 24 ancestors has a recall.
- Of its descendants, K222201 (Medlander Medical Technology, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K080950.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
As a powered muscle stimulator the Biofeedback Nerve and Muscle Stimulator 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 biofeedback device the Biofeedback Nerve and Muscle Stimulator is indicated for…
Read the full statement (144 words)
As a powered muscle stimulator the Biofeedback Nerve and Muscle Stimulator 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 biofeedback device the Biofeedback Nerve and Muscle Stimulator is indicated for the following conditions:
-Biofeedback, relaxation and muscle re-education purposes
As a nonimplanted electrical continence device the Biofeedback Nerve and Muscle Stimulator 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 as stated in the FDA summary.
https://510kreport.com/device/K202648 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202648: Biofeedback Nerve and Muscle Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202648
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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