510(k) · Cleared
ClearedNeurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Roundwhale Technology Co., Ltd. · GXY Electrode, Cutaneous
Cleared on Jan 11, 2024 as substantially equivalent to K203158 (Biowave Corporation, 2021) and 2 other predicates after a 111-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Jan 11, 2024
- Review
- 111 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K932299 (1994). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK932299 Electro-MeshPrizm Medical, Inc. · 1994
- 4 generations backK053214 Theraknit Garment ElectrodeNeurotron Medical · 2005
- 3 generations backK171721 Electrodes with silver conductiveShenzhen Konmed Technology Co., Ltd. · 2018
- 2 generations backK171798 Silverwear Silver Pro Garment DeviceMedia Plus, LLC · 2018
- 1 generation backK203158 BioWave BioWrapsBiowave Corporation · 2021
- This deviceK232995 Neurological Therapy Devices - Accessories: Electrotherapy device…Shenzhen Roundwhale Technology Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K932299 | Electro-Mesh | Prizm Medical, Inc. | 1994 | — |
| −4 | K053214 | Theraknit Garment Electrode | Neurotron Medical | 2005 | — |
| −3 | K171721 | Electrodes with silver conductive | Shenzhen Konmed Technology Co., Ltd. | 2018 | — |
| −2 | K171798 | Silverwear Silver Pro Garment Device | Media Plus, LLC | 2018 | — |
| −1 | K203158 | BioWave BioWraps | Biowave Corporation | 2021 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K203158 | BioWave BioWrapsSummary page 8…Page 2 of 10 3. Predicate Device: 510(K) Trade or Proprietary or Model Name Manufacturer K203158 BioWave BioWraps BioWave Corporation K171798… | 2021 |
| * | K171798 | Silverwear Silver Pro Garment DeviceSummary page 8…or Proprietary or Model Name Manufacturer K203158 BioWave BioWraps BioWave Corporation K171798 Silverwear Silver Pro Garment Device Media Plus, LLC K171721 El… | 2018 |
| * | K171721 | Electrodes with silver conductiveSummary page 8…BioWraps BioWave Corporation K171798 Silverwear Silver Pro Garment Device Media Plus, LLC K171721 Electrodes with Silver Conductive Shenzhen Konmed… | 2018 |
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 30 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K203158.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Neurological Theray Devices - Accessories including Garment 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 summary.
https://510kreport.com/device/K232995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232995: Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232995
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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