510(k) · Cleared

Cleared

Electromed Reusable Neurostimulation Electrodes

K030800510(k) TraditionalCleared Jun 11, 200390-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

Eletromed, Inc. · GXY Electrode, Cutaneous

Cleared on Jun 11, 2003 as substantially equivalent to K963125 (M & R Mfg., Inc., 1997) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1990.

Decided: Jun 11, 2003
Review: 90 days
Class: Class II
Product code: GXY
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K903402 (1990). 3 ancestors in all. No later device cites it as a predicate yet.

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 deviceK030800 Electromed Reusable Neurostimulation ElectrodesEletromed, Inc. · 2003

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)	K030800	Electromed Reusable Neurostimulation Electrodes	Eletromed, Inc.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

FIG. 1 — Lineage of K030800, 1990–2003Source: 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
*	K963125	M and R Reusable Electrodes (Multiple) Summary page 1 …able Neurostimulation Electrodes Common Name: Neurostimulation Electrodes Classification Name: Electrodes, cutaneous Predicate Device: K963125 (M & R Manufacturing, Inc.) K932849 (Pepin Mfg., Inc.) Description of Device: Electrodes, cutan…	M & R Mfg., Inc.	1997	—
*	K932849	Pmi Tens Electrode Summary page 1 …urostimulation Electrodes Classification Name: Electrodes, cutaneous Predicate Device: K963125 (M & R Manufacturing, Inc.) K932849 (Pepin Mfg., Inc.) Description of Device: Electrodes, cutaneous Intended Use: Electromed Reusable Neurostimu…	Pepin Mfg., Inc.	1994	—

Also cleared against K963125: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 13 years and passes through 3 companies; a new generation was cleared every 6.5 years on median.
None of the 3 ancestors has a recall.
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?

Electromed Reusable Neurostimulation Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Electromed 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 this device to sale by or on the order of a physician.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030800 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030800: Electromed Reusable Neurostimulation Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030800

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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