510(k) · Cleared

Cleared

Tens/Fes/Nmes Electrodes

K983097510(k) TraditionalCleared Sep 17, 1999389-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

Uni-Patch, Inc. · GXY Electrode, Cutaneous

Cleared on Sep 17, 1999 as substantially equivalent to K871222 (Uni-Patch, Inc., 1987) and 1 other predicate after a 389-day review. Its family tree reaches back 1 generation to 1987. 8 later devices descend from it.

Decided: Sep 17, 1999
Review: 389 days
Class: Class II
Product code: GXY
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K871222 (1987). 2 ancestors in all. 8 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK871222 Tantone Multi-Day #633 Tens ElectrodeUni-Patch, Inc. · 1987
This deviceK983097 Tens/Fes/Nmes ElectrodesUni-Patch, Inc. · 1999
Descendant · cites it directly · 6 of its ownK070807 Cutaneous Electrotherapy and Recording Electrodes; Tens ElectrodesPepin Mfg., Inc. · 2007
Descendant · 2 generations on · 4 of its ownK080386 Columbia 600 Electrode, Columbia 06 LeadwireColumbia Scientific Development, LLC · 2008
Descendant · 3 generations on · 3 of its ownK083756 Guardian 150 ElectrodeSelectivemed Components, Inc. · 2009
Descendant · 3 generations on · 1 of its ownK121483 Reusable Cutaneous ElectrodeAmpcare, LLC · 2012
Descendant · 4 generations on · 0 of its ownK172887 XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II…Guangzhou Xinbo Electronic Co., Ltd. · 2018

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2004high 1 (2004) · low 0 (2005)2026

Most influential descendants

Showing 5 of 8 · See all

K070807Cutaneous Electrotherapy and Recording Electrodes; Tens ElectrodesPepin Mfg., Inc. · 2007 · cites it directly6descendants
K080386Columbia 600 Electrode, Columbia 06 LeadwireColumbia Scientific Development, LLC · 2008 · 2 generations on4descendants
K083756Guardian 150 ElectrodeSelectivemed Components, Inc. · 2009 · 3 generations on3descendants
K121483Reusable Cutaneous ElectrodeAmpcare, LLC · 2012 · 3 generations on1descendant
K172887XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro -…Guangzhou Xinbo Electronic Co., Ltd. · 2018 · 4 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K871222	Tantone Multi-Day #633 Tens Electrode	Uni-Patch, Inc.	1987	—
0 (this device)	K983097	Tens/Fes/Nmes Electrodes	Uni-Patch, Inc.	1999	—
+1	K070807	Cutaneous Electrotherapy and Recording Electrodes; Tens Electrodes	Pepin Mfg., Inc.	2007	—
+2	K080386	Columbia 600 Electrode, Columbia 06 Leadwire	Columbia Scientific Development, LLC	2008	—
+3	K083756	Guardian 150 Electrode	Selectivemed Components, Inc.	2009	—
+3	K121483	Reusable Cutaneous Electrode	Ampcare, LLC	2012	—
+4	K172887	XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck…	Guangzhou Xinbo Electronic Co., Ltd.	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2007	1	0
2008	1	0
2009	1	0
2011	1	0
2012	1	0
2013	1	0
2018	1	0

FIG. 1 — Lineage of K983097, 1987–2018Source: 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

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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
*	K871222	Tantone Multi-Day #633 Tens Electrode Summary page 4 …cation process. i Uni-Patch currently manufactures and distributes the following electrodes carrying the same indication for use, Tantone Multi-Day 633 TENS Electrode — K871222 Reusable TENS Paravertebral Pad 641 Back Electrode — K901575A Uni-Patch proposes to manufacture and market this electrode family…	Uni-Patch, Inc.	1987	—
*	K901575	Reusable Tens Paravertebral Pad #641 Back Electrod Summary page 4 …butes the following electrodes carrying the same indication for use, Tantone Multi-Day 633 TENS Electrode — K871222 Reusable TENS Paravertebral Pad 641 Back Electrode — K901575A Uni-Patch proposes to manufacture and market this electrode family with conductive gel using similar designs and compositions…	Pioneering Technologies, Inc.	1990	1
†	K851303	Comfort-Ease Electrode	Medtronic Vascular	1985	—
†	K905539	3M 6830 Electrode	3M Healthcare	1991	—

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K070807	Cutaneous Electrotherapy and Recording Electrodes; Tens Electrodes	Pepin Mfg., Inc.	2007	6
K041902	Mantra Electrode	Mantra Intl. (Hk), Ltd.	2004	0

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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K070807 (Pepin Mfg., Inc., 2007) has gone furthest, with 6 descendants of its own.

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?

To conduct electrical stimulation to a patient's skin.

Single use.

Repositionable, self-adhering.

Over-the-counter use.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K983097 · printed Nov 4, 2026

Cite this page

510(k) Report. “K983097: Tens/Fes/Nmes Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983097

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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