510(k) · Cleared
ClearedZekang Self-adhesive Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangsu Zekang Medical Technology Co., Ltd. · GXY Electrode, Cutaneous
Cleared on Aug 25, 2015 as substantially equivalent to K130987 (Axelgaard Mfg. Co., Ltd., 2013) and 1 other predicate after a 134-day review. Its family tree reaches back 6 generations to 1995. 5 later devices descend from it.
- Decided
- Aug 25, 2015
- Review
- 134 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K945676 (1995). 19 ancestors in all, the oldest K903402 (1990). 5 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK945676 Guardian Disposable Tens and Tens/Nmes ElectrodesSelectivemed Components, Inc. · 1995
- 5 generations backK050469 EZ-Stik ElectrodesNaimco, Inc. · 2005 · Recalled
- 4 generations backK052875 Prostim Reusable Neurostimulation ElectrodesSummit Manufacturing, LLC · 2005
- 3 generations backK062675 Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap…Gemore Technology Co, Ltd. · 2007
- 2 generations backK083302 Lifecare ElectrodesEveryway Medical Instruments Co.,Ltd · 2009
- 1 generation backK130987 Valutrode Neurostimlation ElectrodesAxelgaard Mfg. Co., Ltd. · 2013
- This deviceK150971 Zekang Self-adhesive ElectrodeJiangsu Zekang Medical Technology Co., Ltd. · 2015
- Descendant · cites it directly · 4 of its ownK152648 Ennova Self-adhesive ElectrodeSuzhou Ennova Electronics Technology Co.,Ltd · 2016
- Descendant · 2 generations on · 3 of its ownK182111 DL Self-adhesive ElectrodeShaoxing DL Healthcare Co., Ltd. · 2019
- Descendant · 3 generations on · 1 of its ownK241512 Electrode PadShenzhen Deliduo Medical Technology Co.,Ltd · 2025
- Descendant · 4 generations on · 0 of its ownK253237 Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm…Elde Medikal Sanayi ve Ticaret Anonim Sirketi · 2026
- Descendant · 2 generations on · 0 of its ownK183154 SM ElectrodesHong Qiangxing (Shenzhen) Electronics Limited · 2019
Most influential descendants
Showing 5 of 5 · See all- K152648Ennova Self-adhesive ElectrodeSuzhou Ennova Electronics Technology Co.,Ltd · 2016 · cites it directly4descendants
- K182111DL Self-adhesive ElectrodeShaoxing DL Healthcare Co., Ltd. · 2019 · 2 generations on3descendants
- K241512Electrode PadShenzhen Deliduo Medical Technology Co.,Ltd · 2025 · 3 generations on1descendant
- K253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)Elde Medikal Sanayi ve Ticaret Anonim Sirketi · 2026 · 4 generations on0descendants
- K183154SM ElectrodesHong Qiangxing (Shenzhen) Electronics Limited · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945676 | Guardian Disposable Tens and Tens/Nmes Electrodes | Selectivemed Components, Inc. | 1995 | — |
| −5 | K050469 | EZ-Stik Electrodes | Naimco, Inc. | 2005 | 4 |
| −4 | K052875 | Prostim Reusable Neurostimulation Electrodes | Summit Manufacturing, LLC | 2005 | — |
| −3 | K062675 | Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap Series and… | Gemore Technology Co, Ltd. | 2007 | — |
| −2 | K083302 | Lifecare Electrodes | Everyway Medical Instruments Co.,Ltd | 2009 | — |
| −1 | K130987 | Valutrode Neurostimlation Electrodes | Axelgaard Mfg. Co., Ltd. | 2013 | — |
| 0 (this device) | K150971 | Zekang Self-adhesive Electrode | Jiangsu Zekang Medical Technology Co., Ltd. | 2015 | — |
| +1 | K152648 | Ennova Self-adhesive Electrode | Suzhou Ennova Electronics Technology Co.,Ltd | 2016 | — |
| +2 | K182111 | DL Self-adhesive Electrode | Shaoxing DL Healthcare Co., Ltd. | 2019 | — |
| +3 | K241512 | Electrode Pad | Shenzhen Deliduo Medical Technology Co.,Ltd | 2025 | — |
| +4 | K253237 | Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) | Elde Medikal Sanayi ve Ticaret Anonim Sirketi | 2026 | — |
| +2 | K183154 | SM Electrodes | Hong Qiangxing (Shenzhen) Electronics Limited | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 2 | 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 |
|---|---|---|---|
| * | K130987 | Valutrode Neurostimlation ElectrodesSummary page 5…and so on. 3. Predicate Device Identification 510k number Device name Manufacturer Date cleared K130987 ValuTrode® Neurostimulation Electrodes Axelgaard Manufacturing Co., Ltd. 2013 K090198 Jiajia… | 2013 |
| * | K090198 | Jiajian Self-Adhesive ElectrodeSummary page 5…facturer Date cleared K130987 ValuTrode® Neurostimulation Electrodes Axelgaard Manufacturing Co., Ltd. 2013 K090198 Jiajian Self-adhesive Electrode Wuxi Jiajian Medical Instrument Co., Ltd 2009 4. Substantially Equ… | 2009 |
| † | K100418 | Superior Starburst Reusable Self-Adhering Tens/Nmes/Fes Stimulating Electrode | 2010 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152648 | Ennova Self-adhesive Electrode | 2016 | 4 |
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 20 years and passes through 7 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K152648 (Suzhou Ennova Electronics Technology Co.,Ltd, 2016) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K130987.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Zekang Self-Adhesive Electrode is intended to transmit electrical current to patient skin for use with transcutaneous electrical stimulation devices. Some common types of the stimulation devices include, but are not limited to TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The-Counter) or Prescription use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150971 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150971: Zekang Self-adhesive Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150971
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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