510(k) · Cleared
ClearedValutrode Neurostimlation Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axelgaard Mfg. Co., Ltd. · GXY Electrode, Cutaneous
Cleared on Jul 17, 2013 as substantially equivalent to K083302 (Everyway Medical Instruments Co.,Ltd, 2009) and 1 other predicate after a 99-day review. Its family tree reaches back 5 generations to 1995. 10 later devices descend from it.
- Decided
- Jul 17, 2013
- Review
- 99 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K945676 (1995). 10 ancestors in all. 10 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK945676 Guardian Disposable Tens and Tens/Nmes ElectrodesSelectivemed Components, Inc. · 1995
- 4 generations backK050469 EZ-Stik ElectrodesNaimco, Inc. · 2005 · Recalled
- 3 generations backK052875 Prostim Reusable Neurostimulation ElectrodesSummit Manufacturing, LLC · 2005
- 2 generations backK062675 Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap…Gemore Technology Co, Ltd. · 2007
- 1 generation backK083302 Lifecare ElectrodesEveryway Medical Instruments Co.,Ltd · 2009
- This deviceK130987 Valutrode Neurostimlation ElectrodesAxelgaard Mfg. Co., Ltd. · 2013
- Descendant · cites it directly · 5 of its ownK150971 Zekang Self-adhesive ElectrodeJiangsu Zekang Medical Technology Co., Ltd. · 2015
- Descendant · 2 generations on · 4 of its ownK152648 Ennova Self-adhesive ElectrodeSuzhou Ennova Electronics Technology Co.,Ltd · 2016
- Descendant · 3 generations on · 3 of its ownK182111 DL Self-adhesive ElectrodeShaoxing DL Healthcare Co., Ltd. · 2019
- Descendant · 4 generations on · 1 of its ownK241512 Electrode PadShenzhen Deliduo Medical Technology Co.,Ltd · 2025
- Descendant · cites it directly · 1 of its ownK140586 Ascend ElectrodeNeurometrix, Inc. · 2014
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K150971Zekang Self-adhesive ElectrodeJiangsu Zekang Medical Technology Co., Ltd. · 2015 · cites it directly5descendants
- K152648Ennova Self-adhesive ElectrodeSuzhou Ennova Electronics Technology Co.,Ltd · 2016 · 2 generations on4descendants
- K182111DL Self-adhesive ElectrodeShaoxing DL Healthcare Co., Ltd. · 2019 · 3 generations on3descendants
- K241512Electrode PadShenzhen Deliduo Medical Technology Co.,Ltd · 2025 · 4 generations on1descendant
- K140586Ascend ElectrodeNeurometrix, Inc. · 2014 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945676 | Guardian Disposable Tens and Tens/Nmes Electrodes | Selectivemed Components, Inc. | 1995 | — |
| −4 | K050469 | EZ-Stik Electrodes | Naimco, Inc. | 2005 | 4 |
| −3 | K052875 | Prostim Reusable Neurostimulation Electrodes | Summit Manufacturing, LLC | 2005 | — |
| −2 | K062675 | Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap Series and… | Gemore Technology Co, Ltd. | 2007 | — |
| −1 | K083302 | Lifecare Electrodes | Everyway Medical Instruments Co.,Ltd | 2009 | — |
| 0 (this device) | K130987 | Valutrode Neurostimlation Electrodes | Axelgaard Mfg. Co., Ltd. | 2013 | — |
| +1 | K150971 | Zekang Self-adhesive Electrode | Jiangsu Zekang Medical Technology Co., Ltd. | 2015 | — |
| +2 | K152648 | Ennova Self-adhesive Electrode | Suzhou Ennova Electronics Technology Co.,Ltd | 2016 | — |
| +3 | K182111 | DL Self-adhesive Electrode | Shaoxing DL Healthcare Co., Ltd. | 2019 | — |
| +4 | K241512 | Electrode Pad | Shenzhen Deliduo Medical Technology Co.,Ltd | 2025 | — |
| +1 | K140586 | Ascend Electrode | Neurometrix, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2019 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 GXY? 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 GXY device
- #1 K232052 Ceribell Instant EEG Headbandscore 16.3 · 6 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 |
|---|---|---|---|
| * | K083302 | Lifecare ElectrodesSummary page 1…tion is delivered via a connector lead wire stripped to an additional length, or use of a printed silver pattern. Everyway Medical manufactures the Lifecare Electrode (1<083302) with the same conductive hydrogel, conductive carbon film and electrode carrier liner as Axelgaard's ValuTrode Neurostimulation… | 2009 |
| * | K970426 | ValuetrodeSummary page 1…Instruments Company ValuTrode® Neurostimulation Electrodes Axelgaard Manufacturing K970426 1997 Co., Ltd. (The Substantial Equivalency Summary and subseq… | 1997 |
What descends from it? (10)
4 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 18 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K150971 (Jiangsu Zekang Medical Technology Co., Ltd., 2015) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K083302.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · GXY
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXY
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXY
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXY
58in 2025
MAUDE reports naming product code GXY, 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 | 7 | 88 | 0 | 14 |
| 2008 | 9 | 136 | 0 | 17 |
| 2009 | 17 | 159 | 4 | 15 |
| 2010 | 3 | 137 | 1 | 14 |
| 2011 | 6 | 183 | 5 | 16 |
| 2012 | 9 | 150 | 4 | 16 |
| 2013 | 7 | 99 | 0 | 15 |
| 2014 | 9 | 203 | 0 | 11 |
| 2015 | 6 | 119 | 0 | 19 |
| 2016 | 6 | 170 | 0 | 15 |
| 2017 | 9 | 116 | 0 | 11 |
| 2018 | 14 | 135 | 0 | 10 |
| 2019 | 9 | 113 | 0 | 19 |
| 2020 | 4 | 108 | 0 | 11 |
| 2021 | 12 | 195 | 0 | 21 |
| 2022 | 5 | 81 | 0 | 34 |
| 2023 | 13 | 132 | 2 | 25 |
| 2024 | 7 | 111 | 0 | 51 |
| 2025 | 6 | 148 | 0 | 58 |
| 2026 | 12 | 70 | 0 | — |
What is it indicated for?
ValuTrode® reusable, self-adhering, over-the-counter Neurostimulation Electrodes are indicated for use with transcutaneous electrical stimulation devices. Some common types of transcutaneous stimulation devices include, but are not limited to, transepithelial nerve stimulation (TENS) and electrical muscle stimulation (EMS) devices. Transcutaneous Neurostimulation Electrodes are passive devices serving as an interface between a user's skin and a neurostimulation device.
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/K130987 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130987: Valutrode Neurostimlation Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130987
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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