510(k) · Cleared
ClearedM and R Reusable Electrodes (Multiple)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
M & R Mfg., Inc. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Feb 6, 1997 as substantially equivalent to K903402 (Medi-Source, Inc., 1990) after a 178-day review. Its family tree reaches back 1 generation to 1990. 34 later devices descend from it.
- Decided
- Feb 6, 1997
- Review
- 178 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K903402 (1990). 34 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK903402 Geohesive (TM), Model Numbers 1022L, 1023L, 1026LMedi-Source, Inc. · 1990
- This deviceK963125 M and R Reusable Electrodes (Multiple)M & R Mfg., Inc. · 1997
- Descendant · cites it directly · 32 of its ownK020735 Sof-Pach Reusable Neurostimulation ElectrodesCathay International, Ltd. · 2002
- Descendant · 2 generations on · 31 of its ownK080276 Self-Adhesive ElectrodesCathay Health Care Equipment Manufacturing, Inc. · 2008
- Descendant · 2 generations on · 26 of its ownK090198 Jiajian Self-Adhesive ElectrodeWuxi Jiajian Medical Instrument Co., Ltd. · 2009
- Descendant · 3 generations on · 16 of its ownK132998 Wandy Self-Adhesive ElectrodesWandy Rubber Industrial Co., Ltd. · 2013
- Descendant · 4 generations on · 15 of its ownK160138 Adhesive ElectrodesGmdasz Manufacturing Co., Ltd. · 2016
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K020735Sof-Pach Reusable Neurostimulation ElectrodesCathay International, Ltd. · 2002 · cites it directly32descendants
- K080276Self-Adhesive ElectrodesCathay Health Care Equipment Manufacturing, Inc. · 2008 · 2 generations on31descendants
- K090198Jiajian Self-Adhesive ElectrodeWuxi Jiajian Medical Instrument Co., Ltd. · 2009 · 2 generations on26descendants
- K132998Wandy Self-Adhesive ElectrodesWandy Rubber Industrial Co., Ltd. · 2013 · 3 generations on16descendants
- K160138Adhesive ElectrodesGmdasz Manufacturing Co., Ltd. · 2016 · 4 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K903402 | Geohesive (TM), Model Numbers 1022L, 1023L, 1026L | Medi-Source, Inc. | 1990 | — |
| 0 (this device) | K963125 | M and R Reusable Electrodes (Multiple) | M & R Mfg., Inc. | 1997 | — |
| +1 | K020735 | Sof-Pach Reusable Neurostimulation Electrodes | Cathay International, Ltd. | 2002 | — |
| +2 | K080276 | Self-Adhesive Electrodes | Cathay Health Care Equipment Manufacturing, Inc. | 2008 | — |
| +2 | K090198 | Jiajian Self-Adhesive Electrode | Wuxi Jiajian Medical Instrument Co., Ltd. | 2009 | — |
| +3 | K132998 | Wandy Self-Adhesive Electrodes | Wandy Rubber Industrial Co., Ltd. | 2013 | — |
| +4 | K160138 | Adhesive Electrodes | Gmdasz Manufacturing Co., Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 0 |
| 2026 | 2 | 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 GZJ? 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 GZJ device
- #1 K252767 actiTENS miniscore 13.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K903402 | Geohesive (TM), Model Numbers 1022L, 1023L, 1026LSummary page 1…itional" NMES, interferential, high-volt pulsed ' galvanic, functional electrical stimulation, etc.). Predicate Device: Medi-Source, 1Inc. GeoHesive Reusable Electrodes K903402. A chart comparing characteristics of M&R Reusable Electrodes to the predicate device, demonstrating substantial equivalence, is… | 1990 |
What descends from it? (34)
See all 342 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?
- Its one ancestor has no recall.
- Of its descendants, K020735 (Cathay International, Ltd., 2002) has gone furthest, with 32 descendants of its own.
How does its category compare?
All GZJ devicesGZJ Stimulator, Nerve, Transcutaneous, For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GZJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZJ
207in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZJ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZJ
13in 2025
MAUDE reports naming product code GZJ, 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 | 13 | 223 | 4 | 4 |
| 2008 | 11 | 136 | 1 | 45 |
| 2009 | 16 | 155 | 0 | 17 |
| 2010 | 5 | 232 | 0 | 22 |
| 2011 | 5 | 168 | 1 | 22 |
| 2012 | 12 | 154 | 0 | 20 |
| 2013 | 2 | — | 0 | 10 |
| 2014 | 4 | 344 | 0 | 23 |
| 2015 | 3 | 202 | 0 | 18 |
| 2016 | 3 | 163 | 0 | 32 |
| 2017 | 3 | 113 | 0 | 58 |
| 2018 | 2 | — | 0 | 21 |
| 2019 | 3 | 156 | 0 | 7 |
| 2020 | 4 | 183 | 0 | 10 |
| 2021 | 3 | 231 | 0 | 5 |
| 2022 | 4 | 175 | 0 | 4 |
| 2023 | 1 | — | 0 | 39 |
| 2024 | 3 | 207 | 0 | 12 |
| 2025 | 1 | — | 0 | 13 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
M&R Reusable Electrodes are intended for single-patient/multiple-application use in TENS ("traditional" TENS, microcurrent TENS, etc.) or NMES ("traditional" NMES, interferential, high-volt pulsed ' galvanic, functional electrical stimulation, etc.).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K963125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963125: M and R Reusable Electrodes (Multiple).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963125
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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