510(k) · Cleared
ClearedSilverwear Silver Pro Garment Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Media Plus, LLC · GXY Electrode, Cutaneous
Cleared on Jun 1, 2018 as substantially equivalent to K053214 (Neurotron Medical, 2005) and 2 other predicates after a 350-day review. Its family tree reaches back 3 generations to 1994. 3 later devices descend from it.
- Decided
- Jun 1, 2018
- Review
- 350 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K932299 (1994). 6 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK932299 Electro-MeshPrizm Medical, Inc. · 1994
- 2 generations backK053214 Theraknit Garment ElectrodeNeurotron Medical · 2005
- 1 generation backK171721 Electrodes with silver conductiveShenzhen Konmed Technology Co., Ltd. · 2018
- This deviceK171798 Silverwear Silver Pro Garment DeviceMedia Plus, LLC · 2018
- Descendant · cites it directly · 2 of its ownK203158 BioWave BioWrapsBiowave Corporation · 2021
- Descendant · 2 generations on · 0 of its ownK261522 BioWave BioWrapsBiowave Corporation · 2026
- Descendant · cites it directly · 0 of its ownK232995 Neurological Therapy Devices - Accessories: Electrotherapy device…Shenzhen Roundwhale Technology Co., Ltd. · 2024
Most influential descendants
Showing 3 of 3 · See all- K203158BioWave BioWrapsBiowave Corporation · 2021 · cites it directly2descendants
- K261522BioWave BioWrapsBiowave Corporation · 2026 · 2 generations on0descendants
- K232995Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for…Shenzhen Roundwhale Technology Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K932299 | Electro-Mesh | Prizm Medical, Inc. | 1994 | — |
| −2 | K053214 | Theraknit Garment Electrode | Neurotron Medical | 2005 | — |
| −1 | K171721 | Electrodes with silver conductive | Shenzhen Konmed Technology Co., Ltd. | 2018 | — |
| 0 (this device) | K171798 | Silverwear Silver Pro Garment Device | Media Plus, LLC | 2018 | — |
| +1 | K203158 | BioWave BioWraps | Biowave Corporation | 2021 | — |
| +2 | K261522 | BioWave BioWraps | Biowave Corporation | 2026 | — |
| +1 | K232995 | Neurological Therapy Devices - Accessories: Electrotherapy device Electrode… | Shenzhen Roundwhale Technology Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K053214 | Theraknit Garment ElectrodeSummary page 5…P 1005, SP 1006, SP 1007, SP 1008, SP 1009 AM 69127438.2 A. Legally Marketed Predicate devices 1. Theraknit Garment Electrodes k053214 2. Cutaneous Electrodes k141076 – secondary predicate B. Device Description The Silverwear Si… | 2005 |
| * | K141076 | Garment ElectrodesSummary page 5…69127438.2 A. Legally Marketed Predicate devices 1. Theraknit Garment Electrodes k053214 2. Cutaneous Electrodes k141076 – secondary predicate B. Device Description The Silverwear SilverPro garment electrodes are conductive garment… | 2014 |
| * | K171721 | Electrodes with silver conductive Cleared while this submission was under review Summary page 6…882.1320 882.1320 same Product k number Applying K053214 K171721 -- code GXY GXY GXY… | 2018 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 24 years and passes through 4 companies; a new generation was cleared every 11.5 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K203158 (Biowave Corporation, 2021) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K053214.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Silverwear SilverPro Series Conductive Garments are cutaneous electrodes to be used with legally marketed TENS or NMES devices. The knitted garment electrodes are non-sterile reusable OTC conductive garments that are intended to deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. These body parts can include hand (glove), wrist (sleeve), elbow or arm (sleeve), knee or leg (sleeve), knee high stockings, ankle (sleeve), back band, and shoulder band.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171798 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171798: Silverwear Silver Pro Garment Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171798
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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