510(k) Report

510(k) · Cleared

Recalled · Class II · 2009

EZ-Stik Electrodes

K050469510(k) TraditionalCleared May 13, 200579-day reviewClass II21 CFR 882.1320Recalls 4

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Naimco, Inc. · GXY Electrode, Cutaneous

Cleared on May 13, 2005 as substantially equivalent to K945676 (Selectivemed Components, Inc., 1995) and 2 other predicates after a 79-day review. Its family tree reaches back 1 generation to 1995. 40 later devices descend from it. It has been recalled 4 times.

Decided
May 13, 2005
Review
79 days
Class
Class II
Product code
GXY
Recalls
4
Predicates
3

Its longest line of descent runs back 1 generation to K945676 (1995). 3 ancestors in all. 40 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor1997: 1 other ancestor2009: 3 descendants cleared2023: 5 descendants cleared2005: 1 descendant cleared2007: 1 descendant cleared2016: 3 descendants cleared2018: 2 descendants cleared2021: 1 descendant cleared2017: 1 descendant cleared2012: 2 descendants cleared2014: 3 descendants cleared2013: 1 descendant cleared2019: 3 descendants cleared2022: 2 descendants cleared2025: 5 descendants cleared2015: 4 descendants cleared2024: 2 descendants cleared2026: 1 descendant clearedK945676 · Guardian Disposable Tens and Tens/Nmes Electrodes · Selectivemed Components, Inc. · 19951995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 6 descendants4 generations forward: 9 descendants5 generations forward: 9 descendants6 generations forward: 5 descendants7 generations forward: 3 descendants8 generations forward: 2 descendants9 generations forward: 1 descendant K945676 · Guardian Disposable Tens and Tens/Nmes Electrodes · Selectivemed Components, Inc. · 19950+5
  1. Root · 1 generation backK945676 Guardian Disposable Tens and Tens/Nmes ElectrodesSelectivemed Components, Inc. · 1995
  2. This deviceK050469 EZ-Stik ElectrodesNaimco, Inc. · 2005
  3. Descendant · cites it directly · 22 of its ownK052875 Prostim Reusable Neurostimulation ElectrodesSummit Manufacturing, LLC · 2005
  4. Descendant · 2 generations on · 21 of its ownK062675 Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap…Gemore Technology Co, Ltd. · 2007
  5. Descendant · cites it directly · 16 of its ownK092546 Gmdasz Tens Electrodes, Models CWN1005, Dia. 5CM, DWN2505, 5CMX5CM…Gmdasz Manufacturing Co., Ltd. · 2009
  6. Descendant · 2 generations on · 15 of its ownK160138 Adhesive ElectrodesGmdasz Manufacturing Co., Ltd. · 2016
  7. Descendant · 3 generations on · 14 of its ownK083302 Lifecare ElectrodesEveryway Medical Instruments Co.,Ltd · 2009

Showing 5 of 40 descendants. See all descendants

Descendants cleared per year

2005: 12007: 12009: 32012: 22013: 12014: 32015: 42016: 32017: 12018: 22019: 32021: 12022: 22023: 52024: 22025: 52026: 1
2005high 5 (2023) · low 0 (2006)2026

Most influential descendants

Showing 5 of 40 · See all
  • K052875Prostim Reusable Neurostimulation ElectrodesSummit Manufacturing, LLC · 2005 · cites it directly22descendants
  • K062675Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap Series and Double…Gemore Technology Co, Ltd. · 2007 · 2 generations on21descendants
  • K092546Gmdasz Tens Electrodes, Models CWN1005, Dia. 5CM, DWN2505, 5CMX5CM, CWN1007.Dia. 7CM…Gmdasz Manufacturing Co., Ltd. · 2009 · cites it directly16descendants
  • K160138Adhesive ElectrodesGmdasz Manufacturing Co., Ltd. · 2016 · 2 generations on15descendants
  • K083302Lifecare ElectrodesEveryway Medical Instruments Co.,Ltd · 2009 · 3 generations on14descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K945676Guardian Disposable Tens and Tens/Nmes ElectrodesSelectivemed Components, Inc.1995—
0 (this device)K050469EZ-Stik ElectrodesNaimco, Inc.2005—
+1K052875Prostim Reusable Neurostimulation ElectrodesSummit Manufacturing, LLC2005—
+2K062675Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap Series and…Gemore Technology Co, Ltd.2007—
+1K092546Gmdasz Tens Electrodes, Models CWN1005, Dia. 5CM, DWN2505, 5CMX5CM…Gmdasz Manufacturing Co., Ltd.2009—
+2K160138Adhesive ElectrodesGmdasz Manufacturing Co., Ltd.2016—
+3K083302Lifecare ElectrodesEveryway Medical Instruments Co.,Ltd2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200710
200930
201220
201310
201430
201540
201630
201710
201820
201930
202110
202220
202350
202420
202550
202610
FIG. 1 — Lineage of K050469, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K232052 Ceribell Instant EEG Headbandscore 16.3 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K945676Guardian Disposable Tens and Tens/Nmes Electrodes
Summary page 1
…EZ-stik Electrodes Common Name: Neurostimulation Electrodes Classification Name: Electrodes, Cutaneous Predicate Device: K945676 (Selective Med Components) K970426 (Axelgaard Manufacturing) K012463…
Selectivemed Components, Inc.1995—
*K970426Valuetrode
Summary page 1
…mulation Electrodes Classification Name: Electrodes, Cutaneous Predicate Device: K945676 (Selective Med Components) K970426 (Axelgaard Manufacturing) K012463 (Everyway Medical) Description of Device: Electrodes, Cu…
Axelgaard Mfg. Co., Ltd.1997—
*K012463Lifecare 5*5 CM Square, Lifecare 4*4 CM Square, Lifecare 5 CM Round, Lifecare 7.5 CM…
Summary page 1
…utaneous Predicate Device: K945676 (Selective Med Components) K970426 (Axelgaard Manufacturing) K012463 (Everyway Medical) Description of Device: Electrodes, Cutaneous Intended Use: The NAImco, Inc. EZ-stik…
Everyway Medical Instruments Co.,Ltd2002—

Also cleared against K945676: 1 other device →

What descends from it? (40)

See all 40

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K052875Prostim Reusable Neurostimulation ElectrodesSummit Manufacturing, LLC200522
K092546Gmdasz Tens Electrodes, Models CWN1005, Dia. 5CM, DWN2505, 5CMX5CM, CWN1007.Dia. 7CM…Gmdasz Manufacturing Co., Ltd.200916
K223775EZ-STIK ElectrodesSouth Dakota Partners20230

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 30, 2009Class IIZ-0815-2013Unknown/Undetermined by firmElectrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
Nov 30, 2009Class IIZ-0816-2013Unknown/Undetermined by firmElectrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
Nov 30, 2009Class IIZ-0817-2013Unknown/Undetermined by firmElectrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
Nov 30, 2009Class IIZ-0818-2013Unknown/Undetermined by firmElectrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K052875 (Summit Manufacturing, LLC, 2005) has gone furthest, with 22 descendants of its own.
  • 1 other device also cites its predicate K945676.

How does its category compare?

All GXY devices

GXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GXY

6in 2025

2007: 72008: 92009: 172010: 32011: 62012: 92013: 72014: 92015: 62016: 62017: 92018: 142019: 92020: 42021: 122022: 52023: 132024: 72025: 62026 (partial year): 12
2007high 17 (2009) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXY

148in 2025

2007: 88 days median2008: 136 days median2009: 159 days median2010: 137 days median2011: 183 days median2012: 150 days median2013: 99 days median2014: 203 days median2015: 119 days median2016: 170 days median2017: 116 days median2018: 135 days median2019: 113 days median2020: 108 days median2021: 195 days median2022: 81 days median2023: 132 days median2024: 111 days median2025: 148 days median2026 (partial year): 70 days median
2007high 203 (2014) · low 81 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GXY

2in 2023

2009: 42010: 12011: 52012: 42023: 2
2007high 5 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GXY

58in 2025

2007: 142008: 172009: 152010: 142011: 162012: 162013: 152014: 112015: 192016: 152017: 112018: 102019: 192020: 112021: 212022: 342023: 252024: 512025: 58
2007high 58 (2025) · low 10 (2018)2025

MAUDE reports naming product code GXY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007788014
20089136017
200917159415
20103137114
20116183516
20129150416
2013799015
20149203011
20156119019
20166170015
20179116011
201814135010
20199113019
20204108011
202112195021
2022581034
202313132225
20247111051
20256148058
202612700—

What is it indicated for?

The NAlmco, Inc. EZ-stik electrodes are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. NAImco's reusable electrodes are designed and intended to be used with marketed, Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation).

Indications for use as stated in the FDA summary.

Also cleared against K945676

1 other device cites the same predicate.

  • K083756Guardian 150 ElectrodeSelectivemed Components, Inc. · 2009

More from Naimco, Inc.

3 FDA decisions under this applicant name. See the company

  • K063135Sonic-StimNaimco, Inc. · 2007
  • K040495Naimco, Inc., Iontophoresis Drug Delivery Electrodes, Models 201-400, 201-401, 201-402, 201-403 and 201-405Naimco, Inc. · 2004

Recent decisions in GXY

The GXY category page

  • K262664Rongjian Self-adhesive ElectrodeBozhou Rongjian Medical Appliance Co., Ltd. · 2026
  • K262654Dexus Prosthetic System (MSL2, MSR2)Zhejiang Qiangnao Technology Co.,Ltd · 2026
  • K260578Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup…Ambu A/S · 2026
  • K261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc. · 2026
  • K261522BioWave BioWrapsBiowave Corporation · 2026

https://510kreport.com/device/K050469 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050469: EZ-Stik Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050469

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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