510(k) · Cleared

Cleared

Prostim Reusable Neurostimulation Electrodes

K052875510(k) TraditionalCleared Dec 27, 200576-day reviewClass II21 CFR 882.1320

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

Summit Manufacturing, LLC · GXY Electrode, Cutaneous

Cleared on Dec 27, 2005 as substantially equivalent to K050469 (Naimco, Inc., 2005) and 1 other predicate after a 76-day review. Its family tree reaches back 2 generations to 1995. 22 later devices descend from it.

Decided: Dec 27, 2005
Review: 76 days
Class: Class II
Product code: GXY
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K945676 (1995). 5 ancestors in all. 22 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK945676 Guardian Disposable Tens and Tens/Nmes ElectrodesSelectivemed Components, Inc. · 1995
1 generation backK050469 EZ-Stik ElectrodesNaimco, Inc. · 2005 · Recalled
This deviceK052875 Prostim Reusable Neurostimulation ElectrodesSummit Manufacturing, LLC · 2005
Descendant · cites it directly · 21 of its ownK062675 Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap…Gemore Technology Co, Ltd. · 2007
Descendant · 2 generations on · 14 of its ownK083302 Lifecare ElectrodesEveryway Medical Instruments Co.,Ltd · 2009
Descendant · 3 generations on · 10 of its ownK130987 Valutrode Neurostimlation ElectrodesAxelgaard Mfg. Co., Ltd. · 2013
Descendant · 4 generations on · 5 of its ownK150971 Zekang Self-adhesive ElectrodeJiangsu Zekang Medical Technology Co., Ltd. · 2015
Descendant · 2 generations on · 5 of its ownK082065 Well Life Self Adhesive Electrode / Models: CM, FA, PU and SPWell-Life Healthcare Limited · 2009

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2007high 4 (2015) · low 0 (2008)2026

Most influential descendants

Showing 5 of 22 · See all

K062675Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap Series and Double…Gemore Technology Co, Ltd. · 2007 · cites it directly21descendants
K083302Lifecare ElectrodesEveryway Medical Instruments Co.,Ltd · 2009 · 2 generations on14descendants
K130987Valutrode Neurostimlation ElectrodesAxelgaard Mfg. Co., Ltd. · 2013 · 3 generations on10descendants
K150971Zekang Self-adhesive ElectrodeJiangsu Zekang Medical Technology Co., Ltd. · 2015 · 4 generations on5descendants
K082065Well Life Self Adhesive Electrode / Models: CM, FA, PU and SPWell-Life Healthcare Limited · 2009 · 2 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K945676	Guardian Disposable Tens and Tens/Nmes Electrodes	Selectivemed Components, Inc.	1995	—
−1	K050469	EZ-Stik Electrodes	Naimco, Inc.	2005	4
0 (this device)	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	—
+2	K083302	Lifecare Electrodes	Everyway Medical Instruments Co.,Ltd	2009	—
+3	K130987	Valutrode Neurostimlation Electrodes	Axelgaard Mfg. Co., Ltd.	2013	—
+4	K150971	Zekang Self-adhesive Electrode	Jiangsu Zekang Medical Technology Co., Ltd.	2015	—
+2	K082065	Well Life Self Adhesive Electrode / Models: CM, FA, PU and SP	Well-Life Healthcare Limited	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2001	1	0
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
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

FIG. 1 — Lineage of K052875, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K050469	EZ-Stik Electrodes Summary page 1 …005 Device Name: ProStim Reusable Neurostimulation Electrodes Classification Name: Neurostimulation Electrodes Predicate devices: K050469 (Naimco, Inc.) K010431 (Lead-Lok, Inc.) Device Description: ProStim Reusable Neurostimu…	Naimco, Inc.	2005	4
*	K010431	Lead-Lok Reusable Tens/ Nmes Electrodes Summary page 1 …eurostimulation Electrodes Classification Name: Neurostimulation Electrodes Predicate devices: K050469 (Naimco, Inc.) K010431 (Lead-Lok, Inc.) Device Description: ProStim Reusable Neurostimulation electrodes arc non- sterile, disposable lamina…	Lead-Lok, Inc.	2001	—
†	K983741	Everlast Neurostimulation Electrodes 2X 2,Model # EL2020	Axelgaard Mfg. Co., Ltd.	1998	—
†	K962910	Spec T.E.N.S. Prewired Repositionable Tens Electrode - Modify	Uni-Patch, Inc.	1996	—
†	K980229	MSB Tens Electrodes (Disposable)	Msb, Ltd.	1998	—
†	K946230	Endura Reusable Tens and Nmes Electrodes	Selectivemed Components, Inc.	1995	—
†	K875284	Medtronic Snap Ease Model 7795 Cutaneous Electrode	Medtronic Vascular	1988	—
†	K895604	Soft-EZ Reusable Self-Adhering Pigtail Electrodes	Medical Design & Manufacturing Corp.	1989	—
†	K900656	Spec T.E.N.S. Prewired Repositionable Tens Elect.	Labeltape Meditect, Inc.	1990	—
†	K902719	Spect.E.N.S. Repostion.-E Foam Pin Type Tens Elect	Labeltape Meditect, Inc.	1990	—
†	K894043	Spect.E.N.S Repositionable, Snap-Type, Tens	Labeltape Meditect, Inc.	1989	—

Also cleared against K050469: 2 other devices →

What descends from it? (22)

See all 22

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K062675	Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap Series and Double…	Gemore Technology Co, Ltd.	2007	21

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 10 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
1 of the 5 ancestors has a recall of any class.
Of its descendants, K062675 (Gemore Technology Co, Ltd., 2007) has gone furthest, with 21 descendants of its own.
2 other devices also cite its predicate K050469.

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

2007high 17 (2009) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXY

148in 2025

2007high 203 (2014) · low 81 (2022)2026

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

Recalls per year · GXY

2in 2023

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

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

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 ProStim Reusable Neurostimulation Electrodes are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. ProStim Reusable Neurostimulation Electrodes 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) or PGF (Pulsed Galvanic Stimulation).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052875 · printed Nov 5, 2026

Cite this page

510(k) Report. “K052875: Prostim Reusable Neurostimulation Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052875

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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