510(k) · Cleared
ClearedWrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX-WRIST01; GMX-ELBOW01; GMX-LEG01, GMX-ANKLE01, GMX-KNEE01; GMX-FOOT PAD01; GMX-GLOVES01; SHOULDER01; GMX-NCK01)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gymmax Technology Shenzhen Co., Ltd. · GXY Electrode, Cutaneous
Cleared on Jun 10, 2024 as substantially equivalent to K210383 (Hi-Dow International, Inc., 2021) and 1 other predicate after a 146-day review. Its family tree reaches back 1 generation to 2019.
- Decided
- Jun 10, 2024
- Review
- 146 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K190617 (2019). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK190617 Wrap accessory electrodesHi-Dow International, Inc. · 2019
- This deviceK240108 Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02…Gymmax Technology Shenzhen Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K190617 | Wrap accessory electrodes | Hi-Dow International, Inc. | 2019 | — |
| 0 (this device) | K240108 | Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX-WRIST01… | Gymmax Technology Shenzhen Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (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 | Decided |
|---|---|---|---|
| * | K210383 | Wrap Accessory ElectrodesSummary page 5…R 882.1320 Regulatory Class: Class II Review Panel: Neurology Trade Name: Wrap Accessory Electrodes 3. Predicate Device Information1: 510(k) Number: K210383 Predicate Device Name: Wrap Accessory Electrodes Manufacturer: Hi-Dow International Inc. Intended Use: The Wr… | 2021 |
| * | K190617 | Wrap accessory electrodesSummary page 6…can be used for the stimulation on the body areas such as back, neck, shoulder, elbow, wrist, knee and foot. 4. Predicate Device Information2: 510(k) Number: K190617 Predicate Device Name: Wrap accessory electrodes Manufacturer: Hi-Dow International Inc. Intended Use: Wra… | 2019 |
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.
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 Wrap Accessory Electrodes are intended to be used with legally marketed electrical stimulating devices such as transcutaneous electrical nerve stimulators or powered muscle stimulators. The wrap accessory electrodes will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. The wrap accessory electrodes, made up of conductive silicone rubber, can be used for the stimulation on the body areas such as abdomen, neck, shoulder, elbow, leg, hand, wrist, ankle, knee and foot.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240108 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240108: Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX-WRIST01; GMX-ELBOW01; GMX-LEG01, GMX-ANKLE01, GMX-KNEE01; GMX-FOOT PAD01; GMX-GLOVES01; SHOULDER01; GMX-NCK01).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240108
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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