510(k) · Cleared
ClearedOtc Patch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Well-Life Healthcare Limited · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Jan 28, 2014 as substantially equivalent to K052785 (Well-Life Healthcare Limited, 2006) and 2 other predicates after a 53-day review. Its family tree reaches back 5 generations to 1995. 3 later devices descend from it.
- Decided
- Jan 28, 2014
- Review
- 53 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K945676 (1995). 18 ancestors in all, the oldest K940301 (1994). 3 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK945676 Guardian Disposable Tens and Tens/Nmes ElectrodesSelectivemed Components, Inc. · 1995
- 4 generations backK050469 EZ-Stik ElectrodesNaimco, Inc. · 2005 · Recalled
- 3 generations backK052875 Prostim Reusable Neurostimulation ElectrodesSummit Manufacturing, LLC · 2005
- 2 generations backK062675 Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap…Gemore Technology Co, Ltd. · 2007
- 1 generation backK082065 Well Life Self Adhesive Electrode / Models: CM, FA, PU and SPWell-Life Healthcare Limited · 2009
- This deviceK133723 Otc PatchWell-Life Healthcare Limited · 2014
- Descendant · cites it directly · 0 of its ownK220524 Well-Life Mini TENS Stimulator (WL-23XXC/WL-23XXE Series)Well-Life Healthcare Limited · 2022
- Descendant · cites it directly · 0 of its ownK151479 EV-820 OTC Pain Relief TENSEveryway Medical Instruments Co.,Ltd · 2015
- Descendant · cites it directly · 0 of its ownK150681 Gemore Otc TensGemore Technology Co, Ltd. · 2015
Most influential descendants
Showing 3 of 3 · See all- K220524Well-Life Mini TENS Stimulator (WL-23XXC/WL-23XXE Series)Well-Life Healthcare Limited · 2022 · cites it directly0descendants
- K151479EV-820 OTC Pain Relief TENSEveryway Medical Instruments Co.,Ltd · 2015 · cites it directly0descendants
- K150681Gemore Otc TensGemore Technology Co, Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945676 | Guardian Disposable Tens and Tens/Nmes Electrodes | Selectivemed Components, Inc. | 1995 | — |
| −4 | K050469 | EZ-Stik Electrodes | Naimco, Inc. | 2005 | 4 |
| −3 | K052875 | Prostim Reusable Neurostimulation Electrodes | Summit Manufacturing, LLC | 2005 | — |
| −2 | K062675 | Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap Series and… | Gemore Technology Co, Ltd. | 2007 | — |
| −1 | K082065 | Well Life Self Adhesive Electrode / Models: CM, FA, PU and SP | Well-Life Healthcare Limited | 2009 | — |
| 0 (this device) | K133723 | Otc Patch | Well-Life Healthcare Limited | 2014 | — |
| +1 | K220524 | Well-Life Mini TENS Stimulator (WL-23XXC/WL-23XXE Series) | Well-Life Healthcare Limited | 2022 | — |
| +1 | K151479 | EV-820 OTC Pain Relief TENS | Everyway Medical Instruments Co.,Ltd | 2015 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K052785 | Otc Tens for Low Back Pain Relief, Model WL-2405 and WL-2406Summary page 1…tion Name: Transcutaneous electrical nerve stimulator. Regulatory Class: 11 Product Code: NUH 3. Information of the 51 0(k) Cleared Device (Predicate Device): K052785: OTC TENS For Low Back Pain Relief! Model WL-2406. K091757: OTC TENS For Arm & Leg Pain Relief! Model WL-2407. 4. Devic… | 2006 |
| * | K091757 | Otc Tens for Arm and Leg Pain Relief, Model WL-2407Summary page 1…Class: 11 Product Code: NUH 3. Information of the 51 0(k) Cleared Device (Predicate Device): K052785: OTC TENS For Low Back Pain Relief! Model WL-2406. K091757: OTC TENS For Arm & Leg Pain Relief! Model WL-2407. 4. Device Description: The OTC Patch, model WL-2406 is a single channel… | 2010 |
| * | K082065 | Well Life Self Adhesive Electrode / Models: CM, FA, PU and SPSummary page 1…6 has its individual stimulation operation cycle. For the device included in this submission, we use the following of our '510(K) legally marketed predicate electrodes: K082065, "Well-Life Self Adhesive Electrode", CM Series! model no. CM-130x70, size l3Ox7Omm, snap type. With the combination of the main… | 2009 |
What descends from it? (3)
3 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?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 18 ancestors has a recall of any class.
- Of its descendants, K220524 (Well-Life Healthcare Limited, 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K052785.
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. 2014, 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 OTC Patch, Model WL-2406, 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/K133723 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133723: Otc Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133723
Report an extraction error
Are you the manufacturer?
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