510(k) · Cleared
ClearedTens Pals Plus
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 Sep 22, 1987 after a 54-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 57 later devices descend from it.
- Decided
- Sep 22, 1987
- Review
- 54 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 0
57 later devices descend from it, 1 citing it directly.
- This deviceK872976 Tens Pals PlusAxelgaard Mfg. Co., Ltd. · 1987
- Descendant · cites it directly · 56 of its ownK050046 Rehabilicare IF 3 Wave Interferential Stimulator System, Model 7110SCompex Technologies, Inc. · 2005
- Descendant · 2 generations on · 26 of its ownK093324 Empi ContinuumEmpi · 2010
- Descendant · 3 generations on · 25 of its ownK124016 Empi PhoenixDjo, LLC · 2013
- Descendant · 4 generations on · 24 of its ownK153704 StriveDjo, LLC · 2016
- Descendant · 2 generations on · 19 of its ownK123354 Revitive IXActegy, Ltd. · 2013
Showing 5 of 57 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 57 · See all- K050046Rehabilicare IF 3 Wave Interferential Stimulator System, Model 7110SCompex Technologies, Inc. · 2005 · cites it directly56descendants
- K093324Empi ContinuumEmpi · 2010 · 2 generations on26descendants
- K124016Empi PhoenixDjo, LLC · 2013 · 3 generations on25descendants
- K153704StriveDjo, LLC · 2016 · 4 generations on24descendants
- K123354Revitive IXActegy, Ltd. · 2013 · 2 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K872976 | Tens Pals Plus | Axelgaard Mfg. Co., Ltd. | 1987 | — |
| +1 | K050046 | Rehabilicare IF 3 Wave Interferential Stimulator System, Model 7110S | Compex Technologies, Inc. | 2005 | — |
| +2 | K093324 | Empi Continuum | Empi | 2010 | — |
| +3 | K124016 | Empi Phoenix | Djo, LLC | 2013 | — |
| +4 | K153704 | Strive | Djo, LLC | 2016 | — |
| +2 | K123354 | Revitive IX | Actegy, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 7 | 0 |
| 2018 | 2 | 0 |
| 2019 | 7 | 0 |
| 2020 | 8 | 0 |
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 3 | 0 |
| 2025 | 6 | 0 |
| 2026 | 4 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (57)
See all 571 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050046 | Rehabilicare IF 3 Wave Interferential Stimulator System, Model 7110S | 2005 | 56 |
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, K050046 (Compex Technologies, Inc., 2005) has gone furthest, with 56 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/K872976 · printed Nov 6, 2026
Cite this page
510(k) Report. “K872976: Tens Pals Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K872976
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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