510(k) · Cleared
ClearedGarment Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Dongdixin Technology Co., Ltd. · GXY Electrode, Cutaneous
Cleared on Nov 14, 2014 after a 203-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Nov 14, 2014
- Review
- 203 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK141076 Garment ElectrodesShenzhen Dongdixin Technology Co., Ltd. · 2014
- Descendant · cites it directly · 3 of its ownK171798 Silverwear Silver Pro Garment DeviceMedia Plus, LLC · 2018
- Descendant · 2 generations on · 2 of its ownK203158 BioWave BioWrapsBiowave Corporation · 2021
- Descendant · 3 generations on · 0 of its ownK261522 BioWave BioWrapsBiowave Corporation · 2026
- Descendant · 2 generations on · 0 of its ownK232995 Neurological Therapy Devices - Accessories: Electrotherapy device…Shenzhen Roundwhale Technology Co., Ltd. · 2024
Most influential descendants
Showing 4 of 4 · See all- K171798Silverwear Silver Pro Garment DeviceMedia Plus, LLC · 2018 · cites it directly3descendants
- K203158BioWave BioWrapsBiowave Corporation · 2021 · 2 generations on2descendants
- K261522BioWave BioWrapsBiowave Corporation · 2026 · 3 generations on0descendants
- K232995Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for…Shenzhen Roundwhale Technology Co., Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K141076 | Garment Electrodes | Shenzhen Dongdixin Technology Co., Ltd. | 2014 | — |
| +1 | K171798 | Silverwear Silver Pro Garment Device | Media Plus, LLC | 2018 | — |
| +2 | K203158 | BioWave BioWraps | Biowave Corporation | 2021 | — |
| +3 | K261522 | BioWave BioWraps | Biowave Corporation | 2026 | — |
| +2 | K232995 | Neurological Therapy Devices - Accessories: Electrotherapy device Electrode… | Shenzhen Roundwhale Technology Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171798 | Silverwear Silver Pro Garment Device | 2018 | 3 |
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?
- Of its descendants, K171798 (Media Plus, LLC, 2018) has gone furthest, with 3 descendants of its own.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · GXY
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXY
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXY
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXY
58in 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 Cutaneous Electrodes including Garment electrodes and Adhesive electrodes, which are intended to be used with legally marketed electrical stimulating devices such as transcutaneous electrical nerve stimulators or powered muscle stimulators. The cutaneous electrodes will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. The Garment electrodes including glove, socks, sleeve, knee belt and back belt which are made up of silver or conductive silicone rubber.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K141076 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141076: Garment Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141076
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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