510(k) · Cleared
ClearedWell Life Self Adhesive Electrode / Models: CM, FA, PU and SP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Well-Life Healthcare Limited · GXY Electrode, Cutaneous
Cleared on Apr 10, 2009 as substantially equivalent to K062675 (Gemore Technology Co, Ltd., 2007) after a 262-day review. Its family tree reaches back 4 generations to 1995. 5 later devices descend from it.
- Decided
- Apr 10, 2009
- Review
- 262 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K945676 (1995). 9 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK945676 Guardian Disposable Tens and Tens/Nmes ElectrodesSelectivemed Components, Inc. · 1995
- 3 generations backK050469 EZ-Stik ElectrodesNaimco, Inc. · 2005 · Recalled
- 2 generations backK052875 Prostim Reusable Neurostimulation ElectrodesSummit Manufacturing, LLC · 2005
- 1 generation backK062675 Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap…Gemore Technology Co, Ltd. · 2007
- This deviceK082065 Well Life Self Adhesive Electrode / Models: CM, FA, PU and SPWell-Life Healthcare Limited · 2009
- Descendant · cites it directly · 3 of its ownK133723 Otc PatchWell-Life Healthcare Limited · 2014
- Descendant · 2 generations on · 0 of its ownK220524 Well-Life Mini TENS Stimulator (WL-23XXC/WL-23XXE Series)Well-Life Healthcare Limited · 2022
- Descendant · 2 generations on · 0 of its ownK151479 EV-820 OTC Pain Relief TENSEveryway Medical Instruments Co.,Ltd · 2015
- Descendant · 2 generations on · 0 of its ownK150681 Gemore Otc TensGemore Technology Co, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK120516 Long Life PadtmOmron Healthcare, Inc. · 2012
Most influential descendants
Showing 5 of 5 · See all- K133723Otc PatchWell-Life Healthcare Limited · 2014 · cites it directly3descendants
- K220524Well-Life Mini TENS Stimulator (WL-23XXC/WL-23XXE Series)Well-Life Healthcare Limited · 2022 · 2 generations on0descendants
- K151479EV-820 OTC Pain Relief TENSEveryway Medical Instruments Co.,Ltd · 2015 · 2 generations on0descendants
- K150681Gemore Otc TensGemore Technology Co, Ltd. · 2015 · 2 generations on0descendants
- K120516Long Life PadtmOmron Healthcare, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945676 | Guardian Disposable Tens and Tens/Nmes Electrodes | Selectivemed Components, Inc. | 1995 | — |
| −3 | K050469 | EZ-Stik Electrodes | Naimco, Inc. | 2005 | 4 |
| −2 | K052875 | Prostim Reusable Neurostimulation Electrodes | Summit Manufacturing, LLC | 2005 | — |
| −1 | K062675 | Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap Series and… | Gemore Technology Co, Ltd. | 2007 | — |
| 0 (this device) | K082065 | Well Life Self Adhesive Electrode / Models: CM, FA, PU and SP | Well-Life Healthcare Limited | 2009 | — |
| +1 | K133723 | Otc Patch | Well-Life Healthcare Limited | 2014 | — |
| +2 | K220524 | Well-Life Mini TENS Stimulator (WL-23XXC/WL-23XXE Series) | Well-Life Healthcare Limited | 2022 | — |
| +2 | K151479 | EV-820 OTC Pain Relief TENS | Everyway Medical Instruments Co.,Ltd | 2015 | — |
| +2 | K150681 | Gemore Otc Tens | Gemore Technology Co, Ltd. | 2015 | — |
| +1 | K120516 | Long Life Padtm | Omron Healthcare, Inc. | 2012 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K062675 | Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap Series and Double…Summary page 1…dentification: Classification Name: Electrode, Cutaneous Trade/Proprietary Name: Well Life Self Adhesive Electrode ICM, FA, PU, and SP series Predicate devices: K062675 (Gemore Technology Cd., Ltd) 3. Dvc ecito Well Life Self Adhesive Electrode /CM, FA, PU, and SP series are non-sterile… | 2007 |
| † | K983741 | Everlast Neurostimulation Electrodes 2X 2,Model # EL2020 | 1998 |
| † | K000947 | Ultrastim Electrode, Model US4040 | 2000 |
What descends from it? (5)
2 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 14 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K133723 (Well-Life Healthcare Limited, 2014) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K062675.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Well Life Self Adhesive Electrode/CM, FA, PU and SP series are intended for use as a disposable,.conductive adhesive interface between the patient's skin and the Electrical Stimulator. Well Life Self Adhesive Electrode / AP, CM, FA, PU and SP 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 Mu'scularfStimulation), IF (Interferential) and PGS (Pulsed Galvanic Stimulation):
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082065 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082065: Well Life Self Adhesive Electrode / Models: CM, FA, PU and SP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082065
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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