510(k) · Cleared
ClearedUltrastim Electrode, Model US4040
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axelgaard Mfg. Co., Ltd. · GXY Electrode, Cutaneous
Cleared on Jun 16, 2000 after an 85-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jun 16, 2000
- Review
- 85 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK000947 Ultrastim Electrode, Model US4040Axelgaard Mfg. Co., Ltd. · 2000
- Descendant · cites it directly · 0 of its ownK131720 Hivox Self Adhesive Electrode Gel PadsHivox Biotek, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK102786 Well-Life Otc Ems SystemWell-Life Healthcare Limited · 2011
- Descendant · cites it directly · 0 of its ownK090951 RS- LB Low Back Conductive Garment, Model RS-LBM, RS-LBL, RS-FBG…Rs Medical · 2009 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K131720Hivox Self Adhesive Electrode Gel PadsHivox Biotek, Inc. · 2014 · cites it directly0descendants
- K102786Well-Life Otc Ems SystemWell-Life Healthcare Limited · 2011 · cites it directly0descendants
- K090951RS- LB Low Back Conductive Garment, Model RS-LBM, RS-LBL, RS-FBG Full Back Conductive…Rs Medical · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000947 | Ultrastim Electrode, Model US4040 | Axelgaard Mfg. Co., Ltd. | 2000 | — |
| +1 | K131720 | Hivox Self Adhesive Electrode Gel Pads | Hivox Biotek, Inc. | 2014 | — |
| +1 | K102786 | Well-Life Otc Ems System | Well-Life Healthcare Limited | 2011 | — |
| +1 | K090951 | RS- LB Low Back Conductive Garment, Model RS-LBM, RS-LBL, RS-FBG Full Back… | Rs Medical | 2009 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
3 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?
- Of its descendants, K131720 (Hivox Biotek, Inc., 2014) has gone furthest, with 0 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.
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 | — |
https://510kreport.com/device/K000947 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000947: Ultrastim Electrode, Model US4040.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000947
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026