510(k) · Cleared
ClearedPmi Tens Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pepin Mfg., Inc. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Jan 27, 1994 after a 231-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 41 later devices descend from it.
- Decided
- Jan 27, 1994
- Review
- 231 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 0
41 later devices descend from it, 3 citing it directly.
- This deviceK932849 Pmi Tens ElectrodePepin Mfg., Inc. · 1994
- 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 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · 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 |
|---|---|---|---|---|---|
| 0 (this device) | K932849 | Pmi Tens Electrode | Pepin Mfg., Inc. | 1994 | — |
| +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 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 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), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (41)
See all 413 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, 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 | — |
https://510kreport.com/device/K932849 · printed Nov 5, 2026
Cite this page
510(k) Report. “K932849: Pmi Tens Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K932849
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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