510(k) · Cleared
ClearedDr-Ho's Foot Pad Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Drtv Asia, Ltd. · GXY Electrode, Cutaneous
Cleared on Oct 9, 2015 as substantially equivalent to K113321 (Savia Limited, 2012) and 1 other predicate after a 108-day review. Its family tree reaches back 4 generations to 2004. 1 later device descends from it.
- Decided
- Oct 9, 2015
- Review
- 108 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K040512 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK040512 Limited Function WL/Otc-Tens Device, Model WL-2103A, WL-2203A…Well-Life Healthcare, Inc. · 2004
- 3 generations backK052785 Otc Tens for Low Back Pain Relief, Model WL-2405 and WL-2406Well-Life Healthcare Limited · 2006
- 2 generations backK063660 Otc Tens for Low Back Pain Relief, Model WL-2407Well-Life Healthcare Limited · 2007
- 1 generation backK113321 Tens Back Pain Relief SystemSavia Limited · 2012
- This deviceK151693 Dr-Ho's Foot Pad ElectrodeDrtv Asia, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK172887 XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II…Guangzhou Xinbo Electronic Co., Ltd. · 2018
Most influential descendants
Showing 1 of 1 · See all- K172887XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro -…Guangzhou Xinbo Electronic Co., Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K040512 | Limited Function WL/Otc-Tens Device, Model WL-2103A, WL-2203A, WL-2203B and… | Well-Life Healthcare, Inc. | 2004 | — |
| −3 | K052785 | Otc Tens for Low Back Pain Relief, Model WL-2405 and WL-2406 | Well-Life Healthcare Limited | 2006 | — |
| −2 | K063660 | Otc Tens for Low Back Pain Relief, Model WL-2407 | Well-Life Healthcare Limited | 2007 | — |
| −1 | K113321 | Tens Back Pain Relief System | Savia Limited | 2012 | — |
| 0 (this device) | K151693 | Dr-Ho's Foot Pad Electrode | Drtv Asia, Ltd. | 2015 | — |
| +1 | K172887 | XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck… | Guangzhou Xinbo Electronic Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K113321 | Tens Back Pain Relief SystemSummary page 4…s: II 3. Predicate (cleared) Devices: Predicate l: TENS BACK PAIN RELIEF SYSTEM, Model EM38 (TENS Belt with sewn-in Electrode Patches) 5l0(k) Number: K113321 Manufacturer: Savia Limited, China Predicate 2: OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407 (TENS Belt wit… | 2012 |
| * | K063660 | Otc Tens for Low Back Pain Relief, Model WL-2407Summary page 4…ufacturer: Savia Limited, China Predicate 2: OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407 (TENS Belt with sewn-in Electrode Patches) 5l0(k) Number: K063660 Manufacturer: Well-Life Healthcare Ltd., Taiwan 4. Description of Proposed Device: The Dr-Ho's Foot Pad Electrod… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172887 | XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro -… | 2018 | 0 |
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 11 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K172887 (Guangzhou Xinbo Electronic Co., Ltd., 2018) 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. 2015, 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 Cutaneous Electrodes, "Dr-Ho's Foot Pad Electrodes", 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 bottom of the feet which they are in contact with.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151693 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151693: Dr-Ho's Foot Pad Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151693
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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