510(k) · Cleared

Cleared

Sof-Pach Reusable Neurostimulation Electrodes

K020735510(k) TraditionalCleared Jul 12, 2002128-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

Cathay International, Ltd. · GXY Electrode, Cutaneous

Cleared on Jul 12, 2002 as substantially equivalent to K963125 (M & R Mfg., Inc., 1997) and 2 other predicates after a 128-day review. Its family tree reaches back 2 generations to 1990. 32 later devices descend from it.

Decided: Jul 12, 2002
Review: 128 days
Class: Class II
Product code: GXY
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K903402 (1990). 4 ancestors in all. 32 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 2 generations backK903402 Geohesive (TM), Model Numbers 1022L, 1023L, 1026LMedi-Source, Inc. · 1990
1 generation backK963125 M and R Reusable Electrodes (Multiple)M & R Mfg., Inc. · 1997
This deviceK020735 Sof-Pach Reusable Neurostimulation ElectrodesCathay International, Ltd. · 2002
Descendant · cites it directly · 31 of its ownK080276 Self-Adhesive ElectrodesCathay Health Care Equipment Manufacturing, Inc. · 2008
Descendant · cites it directly · 26 of its ownK090198 Jiajian Self-Adhesive ElectrodeWuxi Jiajian Medical Instrument Co., Ltd. · 2009
Descendant · 2 generations on · 16 of its ownK132998 Wandy Self-Adhesive ElectrodesWandy Rubber Industrial Co., Ltd. · 2013
Descendant · 3 generations on · 15 of its ownK160138 Adhesive ElectrodesGmdasz Manufacturing Co., Ltd. · 2016
Descendant · 3 generations on · 9 of its ownK180865 ZMI Self-Adhesive ElectrodesZmi Electronics, Ltd. · 2018

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2008high 5 (2025) · low 0 (2010)2026

Most influential descendants

Showing 5 of 32 · See all

K080276Self-Adhesive ElectrodesCathay Health Care Equipment Manufacturing, Inc. · 2008 · cites it directly31descendants
K090198Jiajian Self-Adhesive ElectrodeWuxi Jiajian Medical Instrument Co., Ltd. · 2009 · cites it directly26descendants
K132998Wandy Self-Adhesive ElectrodesWandy Rubber Industrial Co., Ltd. · 2013 · 2 generations on16descendants
K160138Adhesive ElectrodesGmdasz Manufacturing Co., Ltd. · 2016 · 3 generations on15descendants
K180865ZMI Self-Adhesive ElectrodesZmi Electronics, Ltd. · 2018 · 3 generations on9descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K903402	Geohesive (TM), Model Numbers 1022L, 1023L, 1026L	Medi-Source, Inc.	1990	—
−1	K963125	M and R Reusable Electrodes (Multiple)	M & R Mfg., Inc.	1997	—
0 (this device)	K020735	Sof-Pach Reusable Neurostimulation Electrodes	Cathay International, Ltd.	2002	—
+1	K080276	Self-Adhesive Electrodes	Cathay Health Care Equipment Manufacturing, Inc.	2008	—
+1	K090198	Jiajian Self-Adhesive Electrode	Wuxi Jiajian Medical Instrument Co., Ltd.	2009	—
+2	K132998	Wandy Self-Adhesive Electrodes	Wandy Rubber Industrial Co., Ltd.	2013	—
+3	K160138	Adhesive Electrodes	Gmdasz Manufacturing Co., Ltd.	2016	—
+3	K180865	ZMI Self-Adhesive Electrodes	Zmi Electronics, Ltd.	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	1	0
2013	1	0
2015	1	0
2016	3	0
2017	1	0
2018	3	0
2019	3	0
2021	3	0
2022	2	0
2023	4	0
2024	2	0
2025	5	0
2026	2	0

FIG. 1 — Lineage of K020735, 1990–2026Source: 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? (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.

Type	Number	Device	Applicant	Decided	Recalls
*	K963125	M and R Reusable Electrodes (Multiple) Summary page 1 …mrnentKJsual Name: Neurostimulation Electrodes Classification Name: Electrodes, cutaneous Predicate devices: K963 125 (M & R Manufacturing, IC.) K932849 (Pepin Mfg., Inc.)…	M & R Mfg., Inc.	1997	—
*	K932849	Pmi Tens Electrode Summary page 1 …ation Name: Electrodes, cutaneous Predicate devices: K963 125 (M & R Manufacturing, IC.) K932849 (Pepin Mfg., Inc.) KO 11411 (Pain Management Technologies) Device description: SOF-PAC…	Pepin Mfg., Inc.	1994	—
*	K011411	Self-Adhesive Electrodes	Pain Management Technologies	2001	—
†	K962910	Spec T.E.N.S. Prewired Repositionable Tens Electrode - Modify	Uni-Patch, Inc.	1996	—
†	K000870	KM-10 Tens Electrode	Katecho, Inc.	2000	—
†	K980229	MSB Tens Electrodes (Disposable)	Msb, Ltd.	1998	—
†	K983741	Everlast Neurostimulation Electrodes 2X 2,Model # EL2020	Axelgaard Mfg. Co., 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 K963125: 1 other device →

What descends from it? (32)

See all 32

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

Number	Device	Applicant	Decided	Descendants
K080276	Self-Adhesive Electrodes	Cathay Health Care Equipment Manufacturing, Inc.	2008	31
K090198	Jiajian Self-Adhesive Electrode	Wuxi Jiajian Medical Instrument Co., Ltd.	2009	26

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 3 companies; a new generation was cleared every 6.5 years on median.
None of the 4 ancestors has a recall.
Of its descendants, K080276 (Cathay Health Care Equipment Manufacturing, Inc., 2008) has gone furthest, with 31 descendants of its own.
1 other device also cites its predicate K963125.

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?

SOF-PACH™ Reusable Cutaneous Neurostimulation Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. SOF-PACH™ 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) of PGF (Pulsed Galvanic Stimulation).

These electrodes will include the precaution statement: Federal Law restricts the device to sale by or on the order of a licensed practitioner or therapist.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K020735 · printed Nov 4, 2026

Cite this page

510(k) Report. “K020735: Sof-Pach Reusable Neurostimulation Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020735

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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