510(k) · Cleared
ClearedXinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Xinbo Electronic Co., Ltd. · GXY Electrode, Cutaneous
Cleared on Apr 19, 2018 as substantially equivalent to K053214 (Neurotron Medical, 2005) and 2 other predicates after a 210-day review. Its family tree reaches back 6 generations to 1987.
- Decided
- Apr 19, 2018
- Review
- 210 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K871222 (1987). 22 ancestors in all, the oldest K852267 (1985). No later device cites it as a predicate yet.
- Root · 6 generations backK871222 Tantone Multi-Day #633 Tens ElectrodeUni-Patch, Inc. · 1987
- 5 generations backK983097 Tens/Fes/Nmes ElectrodesUni-Patch, Inc. · 1999
- 4 generations backK070807 Cutaneous Electrotherapy and Recording Electrodes; Tens ElectrodesPepin Mfg., Inc. · 2007
- 3 generations backK080386 Columbia 600 Electrode, Columbia 06 LeadwireColumbia Scientific Development, LLC · 2008
- 2 generations backK083756 Guardian 150 ElectrodeSelectivemed Components, Inc. · 2009
- 1 generation backK121483 Reusable Cutaneous ElectrodeAmpcare, LLC · 2012
- This deviceK172887 XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II…Guangzhou Xinbo Electronic Co., Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K871222 | Tantone Multi-Day #633 Tens Electrode | Uni-Patch, Inc. | 1987 | — |
| −5 | K983097 | Tens/Fes/Nmes Electrodes | Uni-Patch, Inc. | 1999 | — |
| −4 | K070807 | Cutaneous Electrotherapy and Recording Electrodes; Tens Electrodes | Pepin Mfg., Inc. | 2007 | — |
| −3 | K080386 | Columbia 600 Electrode, Columbia 06 Leadwire | Columbia Scientific Development, LLC | 2008 | — |
| −2 | K083756 | Guardian 150 Electrode | Selectivemed Components, Inc. | 2009 | — |
| −1 | K121483 | Reusable Cutaneous Electrode | Ampcare, LLC | 2012 | — |
| 0 (this device) | K172887 | XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck… | Guangzhou Xinbo Electronic Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K053214 | Theraknit Garment ElectrodeSummary page 4…709 Device Name Theraknit Garments Electrode Series Electrodes 510(k) Number K053214 K151693 K121483 Product Code GXY GXY… | 2005 |
| * | K151693 | Dr-Ho's Foot Pad ElectrodeSummary page 4…Theraknit Garments Electrode Series Electrodes 510(k) Number K053214 K151693 K121483 Product Code GXY GXY GXY Regulation… | 2015 |
| * | K121483 | Reusable Cutaneous ElectrodeSummary page 4…Electrode Series Electrodes 510(k) Number K053214 K151693 K121483 Product Code GXY GXY GXY Regulation 882.1320… | 2012 |
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 31 years and passes through 6 companies; a new generation was cleared every 5.5 years on median.
- 2 of the 22 ancestors have a recall of any class.
- 5 other devices also cite its predicate K053214.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
XinBo Electrodes (Model: Neck Therapy Pro - I; Neck Therapy Pro – II; Neck Therapy Pro - III, Neck Therapy Pro - IV) are cutaneous electrodes to be used with legally marketed TENS stimulating devices for which stimulation of the back of the neck and upper back is appropriate. They will deliver the stimulation signals generated by the stimulator to the back of the neck, upper back and shoulder surface areas with which they are in contact.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172887 · printed Nov 5, 2026
Cite this page
510(k) Report. “K172887: XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K172887
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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