510(k) · Cleared
ClearedThe Izzzy-Tens (WL-2401), the Slim-Tens (WL-2402), the Mens-Tens (WL2403), the Compact Tens (WL-2302)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Well-Life Healthcare, Inc. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Dec 30, 2002 as substantially equivalent to K002874 (Well-Life Consultant, 2001) after a 361-day review. Its family tree reaches back 1 generation to 2001. 4 later devices descend from it.
- Decided
- Dec 30, 2002
- Review
- 361 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002874 (2001). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK002874 Well-TensWell-Life Consultant · 2001
- This deviceK020020 The Izzzy-Tens (WL-2401), the Slim-Tens (WL-2402), the Mens-Tens…Well-Life Healthcare, Inc. · 2002
- Descendant · cites it directly · 2 of its ownK032928 Mediphysics Pain Treatment System, Model 1Mediphysics Pain Centers of America · 2003
- Descendant · cites it directly · 1 of its ownK070474 Newlife Sciences LLC, Model TMRNewlife Sciences, LLC · 2007
- Descendant · 2 generations on · 0 of its ownK202186 TrueRelief DeviceTruerelief · 2021
- Descendant · cites it directly · 0 of its ownK080304 Pro Tens, Model WL-240 RXWell-Life Healthcare Limited · 2008
Most influential descendants
Showing 4 of 4 · See all- K032928Mediphysics Pain Treatment System, Model 1Mediphysics Pain Centers of America · 2003 · cites it directly2descendants
- K070474Newlife Sciences LLC, Model TMRNewlife Sciences, LLC · 2007 · cites it directly1descendant
- K202186TrueRelief DeviceTruerelief · 2021 · 2 generations on0descendants
- K080304Pro Tens, Model WL-240 RXWell-Life Healthcare Limited · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002874 | Well-Tens | Well-Life Consultant | 2001 | — |
| 0 (this device) | K020020 | The Izzzy-Tens (WL-2401), the Slim-Tens (WL-2402), the Mens-Tens (WL2403), the… | Well-Life Healthcare, Inc. | 2002 | — |
| +1 | K032928 | Mediphysics Pain Treatment System, Model 1 | Mediphysics Pain Centers of America | 2003 | — |
| +1 | K070474 | Newlife Sciences LLC, Model TMR | Newlife Sciences, LLC | 2007 | — |
| +2 | K202186 | TrueRelief Device | Truerelief | 2021 | — |
| +1 | K080304 | Pro Tens, Model WL-240 RX | Well-Life Healthcare Limited | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2021 | 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 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? (1)
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 |
|---|---|---|---|
| * | K002874 | Well-Tens | 2001 |
What descends from it? (4)
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?
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 | — |
What is it indicated for?
The Mini-TENS including a series of TENS models (WL-2401, WL-2402, WL-2403, and WL-2302) is intended for symptomatic relief of chronic intractable pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020020 · printed Nov 3, 2026
Cite this page
510(k) Report. “K020020: The Izzzy-Tens (WL-2401), the Slim-Tens (WL-2402), the Mens-Tens (WL2403), the Compact Tens (WL-2302).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K020020
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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