510(k) · Cleared
ClearedWELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A
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 Dec 5, 2016 after a 193-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Dec 5, 2016
- Review
- 193 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK161453 WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605AWell-Life Healthcare Limited · 2016
- Descendant · cites it directly · 0 of its ownK220997 Wireless TENS/EMS, Bruno, AelaZmi Elecronics, Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K220997Wireless TENS/EMS, Bruno, AelaZmi Elecronics, Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K161453 | WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A | Well-Life Healthcare Limited | 2016 | — |
| +1 | K220997 | Wireless TENS/EMS, Bruno, Aela | Zmi Elecronics, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220997 | Wireless TENS/EMS, Bruno, Aela | 2022 | 0 |
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, K220997 (Zmi Elecronics, Ltd., 2022) has gone furthest, with 0 descendants of its own.
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. 2016, 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?
For temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 through P7) 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.(Choose TENS Modes P1 through P7) For symptomatic relief and management of…
Read the full statement (113 words)
For temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 through P7)
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.(Choose TENS Modes P1 through P7)
For symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. (Choose TENS Modes P8)
For use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P1 through P6)
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K161453 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161453: WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161453
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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