510(k) · Cleared
ClearedBioWave BioWraps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biowave Corporation · GXY Electrode, Cutaneous
Cleared on Jul 8, 2021 as substantially equivalent to K171798 (Media Plus, LLC, 2018) after a 259-day review. Its family tree reaches back 4 generations to 1994. 2 later devices descend from it.
- Decided
- Jul 8, 2021
- Review
- 259 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K932299 (1994). 7 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK932299 Electro-MeshPrizm Medical, Inc. · 1994
- 3 generations backK053214 Theraknit Garment ElectrodeNeurotron Medical · 2005
- 2 generations backK171721 Electrodes with silver conductiveShenzhen Konmed Technology Co., Ltd. · 2018
- 1 generation backK171798 Silverwear Silver Pro Garment DeviceMedia Plus, LLC · 2018
- This deviceK203158 BioWave BioWrapsBiowave Corporation · 2021
- Descendant · cites it directly · 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K932299 | Electro-Mesh | Prizm Medical, Inc. | 1994 | — |
| −3 | K053214 | Theraknit Garment Electrode | Neurotron Medical | 2005 | — |
| −2 | K171721 | Electrodes with silver conductive | Shenzhen Konmed Technology Co., Ltd. | 2018 | — |
| −1 | K171798 | Silverwear Silver Pro Garment Device | Media Plus, LLC | 2018 | — |
| 0 (this device) | K203158 | BioWave BioWraps | Biowave Corporation | 2021 | — |
| +1 | 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 |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K171798 | Silverwear Silver Pro Garment DeviceSummary page 5…K-Number Primary Predicate SilverWear USA, LLC. SilverPro Garment Electrodes K171798 Reference Predicate Shenzhen Konmed Electrodes with Silver Conductive… | 2018 |
| † | K171721 | Electrodes with silver conductive | 2018 |
| † | K944487 | Electro-Mesh Sock, Wrap, and Sleeve Electrodes | 1995 |
What descends from it? (2)
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 27 years and passes through 5 companies; a new generation was cleared every 11.5 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K261522 (Biowave Corporation, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K171798.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 BioWave BioWraps are cutaneous electrodes to be used with legally marketed BioWave branded neurostimulators. The knitted garment electrodes are non-sterile reusable prescription-use and 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 include hand/wrist, elbow, foot/ankle, knee, and lower back.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203158 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203158: BioWave BioWraps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203158
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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