510(k) · Cleared
ClearedStimSox (TM) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stimmed, LLC · IPF Stimulator, Muscle, Powered
Cleared on Apr 15, 2016 as substantially equivalent to K092990 (Advantageous Medical Devices, LLC, 2009) after a 277-day review. Its family tree reaches back 2 generations to 2004. 1 later device descends from it.
- Decided
- Apr 15, 2016
- Review
- 277 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K032954 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK032954 Elpha, Models II 500, II 1000, II 2000, II 3000 and E80Danmeter A/S · 2004
- 1 generation backK092990 Amd 6605 Tens/NmesAdvantageous Medical Devices, LLC · 2009
- This deviceK151922 StimSox (TM) SystemStimmed, LLC · 2016
- Descendant · cites it directly · 0 of its ownK171071 StimSox (TM) SystemStimmed, LLC · 2017
Most influential descendants
Showing 1 of 1 · See all- K171071StimSox (TM) SystemStimmed, LLC · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K032954 | Elpha, Models II 500, II 1000, II 2000, II 3000 and E80 | Danmeter A/S | 2004 | — |
| −1 | K092990 | Amd 6605 Tens/Nmes | Advantageous Medical Devices, LLC | 2009 | — |
| 0 (this device) | K151922 | StimSox (TM) System | Stimmed, LLC | 2016 | — |
| +1 | K171071 | StimSox (TM) System | Stimmed, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 19.7 · 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 |
|---|---|---|---|
| * | K092990 | Amd 6605 Tens/NmesSummary page 4…FR 890.5850) Regulatory Class: Class II Product Code: IPF III. PREDICATE DEVICE Device Name: AMD 6605 TENS/NMES Stimulator 510(k) Number: K092990 To the best of our knowledge, the predicate device has not been the subject of any design related recalls.… | 2009 |
| † | K072799 | Target Sterile Electrode | 2008 |
| † | K101576 | Centerridge Diagnostic Ecg Electrode, Centerridge Monitoring Ecg Electrodes | 2010 |
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 |
|---|---|---|---|
| K171071 | StimSox (TM) System | 2017 | 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 3 companies; a new generation was cleared every 6.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K171071 (Stimmed, LLC, 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
To temporarily increase local blood circulation in healthy leg muscles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151922 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151922: StimSox (TM) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151922
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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