510(k) · Cleared
ClearedMuscle Stimulation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Niveus Medical, Inc. · IPF Stimulator, Muscle, Powered
Cleared on Mar 29, 2013 as substantially equivalent to K083105 (Bio-Medical Research, Ltd., 2009) and 2 other predicates after a 123-day review. Its family tree reaches back 4 generations to 2001. 1 later device descends from it.
- Decided
- Mar 29, 2013
- Review
- 123 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K010782 (2001). 19 ancestors in all, the oldest K926510 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK010782 Transamerican TensTransamerica Medical Systems · 2001
- 3 generations backK020749 Digital Transcutaneous Electrical Nerve Stimulator, Model EV-803…Everyway Medical Instruments Co.,Ltd · 2002
- 2 generations backK071951 Comfy Series: EV-804, EV-805 & EV-806Everyway Medical Instruments Co.,Ltd · 2007
- 1 generation backK080661 Models Tens 7000, Ems 7500 and Twin StimKoalaty Products, Inc. · 2008
- This deviceK123642 Muscle Stimulation SystemNiveus Medical, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK150742 Muscle Stimulation System 110Niveus Medical, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K150742Muscle Stimulation System 110Niveus Medical, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010782 | Transamerican Tens | Transamerica Medical Systems | 2001 | — |
| −3 | K020749 | Digital Transcutaneous Electrical Nerve Stimulator, Model EV-803 Digital Tens | Everyway Medical Instruments Co.,Ltd | 2002 | — |
| −2 | K071951 | Comfy Series: EV-804, EV-805 & EV-806 | Everyway Medical Instruments Co.,Ltd | 2007 | — |
| −1 | K080661 | Models Tens 7000, Ems 7500 and Twin Stim | Koalaty Products, Inc. | 2008 | — |
| 0 (this device) | K123642 | Muscle Stimulation System | Niveus Medical, Inc. | 2013 | — |
| +1 | K150742 | Muscle Stimulation System 110 | Niveus Medical, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 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? (3)
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 |
|---|---|---|---|
| * | K083105 | Kneehab XP Conductive Garment, Type 411Summary page 1…ulator 21 CFR 890.5850 (Product Code IPF) Predicate Devices Bio-Medical Research, Ltd.'s Neurotech Kneehab XP, Type 411 (K083105) Koalaty Products, Inc.'s Twin Stim TENS/EMS Unit (K080661)… | 2009 |
| * | K080661 | Models Tens 7000, Ems 7500 and Twin StimSummary page 1…h, Ltd.'s Neurotech Kneehab XP, Type 411 (K083105) Koalaty Products, Inc.'s Twin Stim TENS/EMS Unit (K080661) CEC Electronica SRL's Combi 8 Max (K(070888) Device Description The Muscle Stimulation System 110 is… | 2008 |
| * | K070888 | Combi 8 MaxSummary page 1…105) Koalaty Products, Inc.'s Twin Stim TENS/EMS Unit (K080661) CEC Electronica SRL's Combi 8 Max (K(070888) Device Description The Muscle Stimulation System 110 is a portable, externally- powered device which… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150742 | Muscle Stimulation System 110 | 2015 | 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 12 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- None of the 19 ancestors has a recall.
- Of its descendants, K150742 (Niveus Medical, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K083105.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Niveus Medical Muscle Stimulation System 110 is indicated for:
* Maintaining or increasing range of motion of the knee joint
* Prevention or retardation of disuse atrophy in the quadriceps
* Muscle re-education of the quadriceps
* Relaxation of muscle spasms
* Increasing local blood circulation
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123642 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123642: Muscle Stimulation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123642
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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