510(k) · Cleared
ClearedLifecare Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Everyway Medical Instruments Co.,Ltd · GXY Electrode, Cutaneous
Cleared on Aug 3, 2009 as substantially equivalent to K012463 (Everyway Medical Instruments Co.,Ltd, 2002) and 1 other predicate after a 266-day review. Its family tree reaches back 4 generations to 1995. 14 later devices descend from it.
- Decided
- Aug 3, 2009
- Review
- 266 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K945676 (1995). 9 ancestors in all. 14 later devices descend from it, 3 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 deviceK083302 Lifecare ElectrodesEveryway Medical Instruments Co.,Ltd · 2009
- Descendant · cites it directly · 10 of its ownK130987 Valutrode Neurostimlation ElectrodesAxelgaard Mfg. Co., Ltd. · 2013
- Descendant · 2 generations on · 5 of its ownK150971 Zekang Self-adhesive ElectrodeJiangsu Zekang Medical Technology Co., Ltd. · 2015
- Descendant · 3 generations on · 4 of its ownK152648 Ennova Self-adhesive ElectrodeSuzhou Ennova Electronics Technology Co.,Ltd · 2016
- Descendant · 4 generations on · 3 of its ownK182111 DL Self-adhesive ElectrodeShaoxing DL Healthcare Co., Ltd. · 2019
- Descendant · cites it directly · 2 of its ownK112312 TheratrodePhoenix Medical Devices, Llp · 2012
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K130987Valutrode Neurostimlation ElectrodesAxelgaard Mfg. Co., Ltd. · 2013 · cites it directly10descendants
- K150971Zekang Self-adhesive ElectrodeJiangsu Zekang Medical Technology Co., Ltd. · 2015 · 2 generations on5descendants
- K152648Ennova Self-adhesive ElectrodeSuzhou Ennova Electronics Technology Co.,Ltd · 2016 · 3 generations on4descendants
- K182111DL Self-adhesive ElectrodeShaoxing DL Healthcare Co., Ltd. · 2019 · 4 generations on3descendants
- K112312TheratrodePhoenix Medical Devices, Llp · 2012 · cites it directly2descendants
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) | K083302 | Lifecare Electrodes | Everyway Medical Instruments Co.,Ltd | 2009 | — |
| +1 | K130987 | Valutrode Neurostimlation Electrodes | Axelgaard Mfg. Co., Ltd. | 2013 | — |
| +2 | K150971 | Zekang Self-adhesive Electrode | Jiangsu Zekang Medical Technology Co., Ltd. | 2015 | — |
| +3 | K152648 | Ennova Self-adhesive Electrode | Suzhou Ennova Electronics Technology Co.,Ltd | 2016 | — |
| +4 | K182111 | DL Self-adhesive Electrode | Shaoxing DL Healthcare Co., Ltd. | 2019 | — |
| +1 | K112312 | Theratrode | Phoenix Medical Devices, Llp | 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 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K012463 | Lifecare 5*5 CM Square, Lifecare 4*4 CM Square, Lifecare 5 CM Round, Lifecare 7.5 CM…Summary page 1…stantial Equivalency is claimed against the following device: * Lifecare electrodes from Everyway Medical Instruments Co., Ltd. 510k# K012463 * Gemore electrodes from Gemore Technology Co. Ltd, 510k# K062675 16-Description of the Device:… | 2002 |
| * | K062675 | Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap Series and Double…Summary page 1…odes from Everyway Medical Instruments Co., Ltd. 510k# K012463 * Gemore electrodes from Gemore Technology Co. Ltd, 510k# K062675 16-Description of the Device: The Lifecare electrodes are constructed with four basic components: a wire; an insulation backin… | 2007 |
What descends from it? (14)
See all 143 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 2.6 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K130987 (Axelgaard Mfg. Co., Ltd., 2013) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K012463.
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 Lifecare electrodes are intended for use with transcutaneous neurostimulation devices as. over the counter. Some common type of neurostimulation devices include, but are not limited to, TENS devices and EMS devices. Transcutaneous neurostimulation electrodes are passive devices serving as an interface between a patient's skin and a neurostimulation device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083302: Lifecare Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083302
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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