510(k) · Cleared
ClearedGemore Otc Tens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gemore Technology Co, Ltd. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on May 12, 2015 as substantially equivalent to K133723 (Well-Life Healthcare Limited, 2014) and 1 other predicate after a 56-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- May 12, 2015
- Review
- 56 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K945676 (1995). 19 ancestors in all, the oldest K940301 (1994). No later device cites it as a predicate yet.
- Root · 6 generations backK945676 Guardian Disposable Tens and Tens/Nmes ElectrodesSelectivemed Components, Inc. · 1995
- 5 generations backK050469 EZ-Stik ElectrodesNaimco, Inc. · 2005 · Recalled
- 4 generations backK052875 Prostim Reusable Neurostimulation ElectrodesSummit Manufacturing, LLC · 2005
- 3 generations backK062675 Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap…Gemore Technology Co, Ltd. · 2007
- 2 generations backK082065 Well Life Self Adhesive Electrode / Models: CM, FA, PU and SPWell-Life Healthcare Limited · 2009
- 1 generation backK133723 Otc PatchWell-Life Healthcare Limited · 2014
- This deviceK150681 Gemore Otc TensGemore Technology Co, Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945676 | Guardian Disposable Tens and Tens/Nmes Electrodes | Selectivemed Components, Inc. | 1995 | — |
| −5 | K050469 | EZ-Stik Electrodes | Naimco, Inc. | 2005 | 4 |
| −4 | K052875 | Prostim Reusable Neurostimulation Electrodes | Summit Manufacturing, LLC | 2005 | — |
| −3 | K062675 | Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap Series and… | Gemore Technology Co, Ltd. | 2007 | — |
| −2 | K082065 | Well Life Self Adhesive Electrode / Models: CM, FA, PU and SP | Well-Life Healthcare Limited | 2009 | — |
| −1 | K133723 | Otc Patch | Well-Life Healthcare Limited | 2014 | — |
| 0 (this device) | K150681 | Gemore Otc Tens | Gemore Technology Co, Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 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 NUH? 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 NUH device
- #1 K190783 Health Expert Electronic Stimulator (model…score 15.8 · 7 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 |
|---|---|---|---|
| * | K133723 | Otc PatchSummary page 4…tion Name: Transcutaneous electrical nerve stimulator. Regulatory Class: II Product Code: NUH 3. Information of the 510(k) Cleared Device (Predicate Device): K133723: OTC Patch/ Model WL-2406. K091757: OTC TENS For Arm & Leg Pain Relief/ Model WL-2407 4. Device Description: The Gem… | 2014 |
| * | K091757 | Otc Tens for Arm and Leg Pain Relief, Model WL-2407Summary page 4…stimulator. Regulatory Class: II Product Code: NUH 3. Information of the 510(k) Cleared Device (Predicate Device): K133723: OTC Patch/ Model WL-2406. K091757: OTC TENS For Arm & Leg Pain Relief/ Model WL-2407 4. Device Description: The Gemore OTC TENS, model GM310PP/GM320PP/GM321P… | 2010 |
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 20 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 19 ancestors has a recall of any class.
- 2 other devices also cite its predicate K133723.
How does its category compare?
All NUH devicesNUH Stimulator, Nerve, Transcutaneous, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · NUH
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NUH
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUH
No recall names NUH since 2007.
Adverse event reports per year · NUH
7in 2025
MAUDE reports naming product code NUH, 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 | 4 | 161 | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 148 | 0 | 0 |
| 2011 | 6 | 231 | 0 | 0 |
| 2012 | 6 | 170 | 0 | 0 |
| 2013 | 10 | 189 | 0 | 1 |
| 2014 | 16 | 212 | 0 | 9 |
| 2015 | 14 | 198 | 0 | 11 |
| 2016 | 13 | 145 | 0 | 13 |
| 2017 | 17 | 155 | 0 | 21 |
| 2018 | 16 | 121 | 0 | 18 |
| 2019 | 19 | 213 | 0 | 5 |
| 2020 | 14 | 147 | 0 | 8 |
| 2021 | 14 | 198 | 0 | 7 |
| 2022 | 20 | 103 | 0 | 2 |
| 2023 | 15 | 127 | 0 | 4 |
| 2024 | 20 | 90 | 0 | 7 |
| 2025 | 15 | 119 | 0 | 7 |
| 2026 | 5 | 137 | 0 | — |
What is it indicated for?
The Gemore OTC TENS, Model GM310PP/GM320PP/GM321PP/GM330PP, is intended for temporary relief
of pain associated with sore and aching muscles in the low back as well as upper and lower extremities
(arm and/or leg) due to strain from exercise or normal household and work activities
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150681 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150681: Gemore Otc Tens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150681
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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