510(k) · Cleared

Cleared

Ultra-Garment Electrode

K993130510(k) TraditionalCleared Dec 17, 199988-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

Newwave Medical, LLC · GXY Electrode, Cutaneous

Cleared on Dec 17, 1999 as substantially equivalent to K943009 (Scientific Medical Devices, Inc., 1995) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1994.

Decided: Dec 17, 1999
Review: 88 days
Class: Class II
Product code: GXY
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K932299 (1994). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK932299 Electro-MeshPrizm Medical, Inc. · 1994
This deviceK993130 Ultra-Garment ElectrodeNewwave Medical, LLC · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K932299	Electro-Mesh	Prizm Medical, Inc.	1994	—
0 (this device)	K993130	Ultra-Garment Electrode	Newwave Medical, LLC	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

FIG. 1 — Lineage of K993130, 1994–1999Source: 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
*	K943009	SMD Electrodes Summary page 1 …5, 1999 Newwave Medical, LLC 1538 Haven Place Allen , TX 75002 (972) 396-5400 Robert Armstrong Ultra Garment Electrode Cutaneous Electrode Class II SMD Electrodes (k943009) Electro-Mesh Glove Electrodes Prizm Medical (K932299) The Ultra Garment Electrode is a Stretchable Electrically Conductive glov…	Scientific Medical Devices, Inc.	1995	—
*	K932299	Electro-Mesh Summary page 1 …, TX 75002 (972) 396-5400 Robert Armstrong Ultra Garment Electrode Cutaneous Electrode Class II SMD Electrodes (k943009) Electro-Mesh Glove Electrodes Prizm Medical (K932299) The Ultra Garment Electrode is a Stretchable Electrically Conductive glove, sock, or sleeve, Reusable. The “Ultra Garment Elec…	Prizm Medical, Inc.	1994	—

Also cleared against K943009: 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?

None of the 2 ancestors has a recall.
1 other device also cites its predicate K943009.

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 “Ultra Garment Electrode” is intended to be used as an electrically conducting garment to be prescribed for usage by a physician for use where an electrode is appropriate.

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/K993130 · printed Nov 5, 2026

Cite this page

510(k) Report. “K993130: Ultra-Garment Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993130

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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