510(k) · Cleared
ClearedGemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap Series and Double Side Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gemore Technology Co, Ltd. · GXY Electrode, Cutaneous
Cleared on Jan 4, 2007 as substantially equivalent to K052875 (Summit Manufacturing, LLC, 2005) and 1 other predicate after a 118-day review. Its family tree reaches back 3 generations to 1995. 21 later devices descend from it.
- Decided
- Jan 4, 2007
- Review
- 118 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K945676 (1995). 8 ancestors in all. 21 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK945676 Guardian Disposable Tens and Tens/Nmes ElectrodesSelectivemed Components, Inc. · 1995
- 2 generations backK050469 EZ-Stik ElectrodesNaimco, Inc. · 2005 · Recalled
- 1 generation backK052875 Prostim Reusable Neurostimulation ElectrodesSummit Manufacturing, LLC · 2005
- This deviceK062675 Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap…Gemore Technology Co, Ltd. · 2007
- Descendant · cites it directly · 14 of its ownK083302 Lifecare ElectrodesEveryway Medical Instruments Co.,Ltd · 2009
- Descendant · 2 generations on · 10 of its ownK130987 Valutrode Neurostimlation ElectrodesAxelgaard Mfg. Co., Ltd. · 2013
- Descendant · 3 generations on · 5 of its ownK150971 Zekang Self-adhesive ElectrodeJiangsu Zekang Medical Technology Co., Ltd. · 2015
- Descendant · cites it directly · 5 of its ownK082065 Well Life Self Adhesive Electrode / Models: CM, FA, PU and SPWell-Life Healthcare Limited · 2009
- Descendant · 4 generations on · 4 of its ownK152648 Ennova Self-adhesive ElectrodeSuzhou Ennova Electronics Technology Co.,Ltd · 2016
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K083302Lifecare ElectrodesEveryway Medical Instruments Co.,Ltd · 2009 · cites it directly14descendants
- K130987Valutrode Neurostimlation ElectrodesAxelgaard Mfg. Co., Ltd. · 2013 · 2 generations on10descendants
- K150971Zekang Self-adhesive ElectrodeJiangsu Zekang Medical Technology Co., Ltd. · 2015 · 3 generations on5descendants
- K082065Well Life Self Adhesive Electrode / Models: CM, FA, PU and SPWell-Life Healthcare Limited · 2009 · cites it directly5descendants
- K152648Ennova Self-adhesive ElectrodeSuzhou Ennova Electronics Technology Co.,Ltd · 2016 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945676 | Guardian Disposable Tens and Tens/Nmes Electrodes | Selectivemed Components, Inc. | 1995 | — |
| −2 | K050469 | EZ-Stik Electrodes | Naimco, Inc. | 2005 | 4 |
| −1 | K052875 | Prostim Reusable Neurostimulation Electrodes | Summit Manufacturing, LLC | 2005 | — |
| 0 (this device) | 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 | — |
| +2 | K130987 | Valutrode Neurostimlation Electrodes | Axelgaard Mfg. Co., Ltd. | 2013 | — |
| +3 | K150971 | Zekang Self-adhesive Electrode | Jiangsu Zekang Medical Technology Co., Ltd. | 2015 | — |
| +1 | K082065 | Well Life Self Adhesive Electrode / Models: CM, FA, PU and SP | Well-Life Healthcare Limited | 2009 | — |
| +4 | K152648 | Ennova Self-adhesive Electrode | Suzhou Ennova Electronics Technology Co.,Ltd | 2016 | — |
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 |
|---|---|---|
| 2009 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 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 |
|---|---|---|---|
| * | K052875 | Prostim Reusable Neurostimulation ElectrodesSummary page 1…es Trade/Proprietary Name: Gemore Reuseable Self Adhesive Electrode / Wire series, Snap series and Double side series Predicate devices: K052875 (Summit Manufacturing L.L.C) K050788 (EVERLIFE Medical Instrument Co., Ltd.) 3. Device Description… | 2005 |
| * | K050788 | EverlifeSummary page 1…lectrode / Wire series, Snap series and Double side series Predicate devices: K052875 (Summit Manufacturing L.L.C) K050788 (EVERLIFE Medical Instrument Co., Ltd.) 3. Device Description Gemore Reuseable Self Adhesive Electrode / Wire series, Snap… | 2005 |
| † | K983741 | Everlast Neurostimulation Electrodes 2X 2,Model # EL2020 | 1998 |
What descends from it? (21)
See all 212 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 12 years and passes through 4 companies; a new generation was cleared every 1.0 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K083302 (Everyway Medical Instruments Co.,Ltd, 2009) has gone furthest, with 14 descendants of its own.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
The Gemore Reuseable Self Adhesive Electrode / Wire series, Snap series, and Double side series are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Gemore Reuseable Self Adhesive Electrode /Wire series, snap series, and double side series are designed and intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), MENS (Microcurrent Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) and PGS (Pulsed Galvanic Stimulation).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062675 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062675: Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap Series and Double Side Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062675
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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