510(k) · Cleared
ClearedOtc Tens for Arm and Leg Pain Relief, Model WL-2407
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 Feb 5, 2010 as substantially equivalent to K033122 (Prizm Medical, Inc., 2004) and 1 other predicate after a 234-day review. Its family tree reaches back 3 generations to 1994. 6 later devices descend from it.
- Decided
- Feb 5, 2010
- Review
- 234 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K940301 (1994). 5 ancestors in all. 6 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 2 generations backK011880 Compex SportCompex S.A. · 2002
- 1 generation backK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- This deviceK091757 Otc Tens for Arm and Leg Pain Relief, Model WL-2407Well-Life Healthcare Limited · 2010
- Descendant · cites it directly · 3 of its ownK133723 Otc PatchWell-Life Healthcare Limited · 2014
- Descendant · cites it directly · 1 of its ownK121353 Mini PatchWell-Life Healthcare Limited · 2012
- Descendant · 2 generations on · 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
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K133723Otc PatchWell-Life Healthcare Limited · 2014 · cites it directly3descendants
- K121353Mini PatchWell-Life Healthcare Limited · 2012 · cites it directly1descendant
- K220524Well-Life Mini TENS Stimulator (WL-23XXC/WL-23XXE Series)Well-Life Healthcare Limited · 2022 · 2 generations on0descendants
- 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 |
|---|---|---|---|---|---|
| −3 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −2 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −1 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| 0 (this device) | K091757 | Otc Tens for Arm and Leg Pain Relief, Model WL-2407 | Well-Life Healthcare Limited | 2010 | — |
| +1 | K133723 | Otc Patch | Well-Life Healthcare Limited | 2014 | — |
| +1 | K121353 | Mini Patch | Well-Life Healthcare Limited | 2012 | — |
| +2 | 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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K033122 | 5000Z System (Otc)Summary page 1…of the Device: OTC TENS for Arm & Leg Pain Relief / Model: WL-2407. 3. Information of the 510(k) Cleared Device (Predicate Device): 1> The Prizm 5000-Z system (K033122) 2> Endurance Therapeutics Ti 040 (K060846). 4. Device Description: The Well Life TENS devices, WL-2407 is the model of O… | 2004 |
| * | K060846 | Therapeutic Massage CompanionSummary page 1…in Relief / Model: WL-2407. 3. Information of the 510(k) Cleared Device (Predicate Device): 1> The Prizm 5000-Z system (K033122) 2> Endurance Therapeutics Ti 040 (K060846). 4. Device Description: The Well Life TENS devices, WL-2407 is the model of OTC TENS intended for temporary relief of pa… | 2007 |
| † | K022494 | Home Care Jelly | 2002 |
What descends from it? (6)
5 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 16 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K133723 (Well-Life Healthcare Limited, 2014) has gone furthest, with 3 descendants of its own.
- 6 other devices also cite its predicate K033122.
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. 2010, 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 TENS for Arm & Leg Pain Relief/ model WL-2407 are intended for temporary relief of pain associated with sore and aching muscles in the 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/K091757 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091757: Otc Tens for Arm and Leg Pain Relief, Model WL-2407.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091757
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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