510(k) · Cleared
Cleared4 Channels Multiple Model Digital Electrical Stimulator, Model Nuvostim IV, WL-2504A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Well-Life Healthcare Limited · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Jun 25, 2010 as substantially equivalent to K033857 (Well-Life Healthcare, Inc., 2003) and 1 other predicate after a 129-day review. Its family tree reaches back 7 generations to 1992.
- Decided
- Jun 25, 2010
- Review
- 129 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K921441 (1992). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK921441 Interferential Stimulator Model Inf 4150/aBiomedical Life Systems, Inc. · 1992
- 6 generations backK952683 Apex Medical Corp. Portable Interferential Stimulation DeviceWholesale Medical Imports, Inc. · 1997
- 5 generations backK024100 IF Series True Sine Interferential Stimulator/Model: WL-2206, Well…Theratech, Inc. · 2003
- 4 generations backK050847 IF True Sine Interferential Stimulator, Model WL-2206ATheratech, Inc. · 2005
- 3 generations backK060975 IF True Sine Interferential Stimulator / Model WL-2206A1 & WI-2206A2Theratech, Inc. · 2006
- 2 generations backK090023 IF Series True Sine Interferential Stimulator, Model: WL-2206B and…Well-Life Healthcare Limited · 2009
- 1 generation backK092763 IF True Sine Interferential Stimulator, WL-2206DWell-Life Healthcare Limited · 2009
- This deviceK100399 4 Channels Multiple Model Digital Electrical Stimulator, Model…Well-Life Healthcare Limited · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K921441 | Interferential Stimulator Model Inf 4150/a | Biomedical Life Systems, Inc. | 1992 | — |
| −6 | K952683 | Apex Medical Corp. Portable Interferential Stimulation Device | Wholesale Medical Imports, Inc. | 1997 | — |
| −5 | K024100 | IF Series True Sine Interferential Stimulator/Model: WL-2206, Well IF, Life IF… | Theratech, Inc. | 2003 | — |
| −4 | K050847 | IF True Sine Interferential Stimulator, Model WL-2206A | Theratech, Inc. | 2005 | — |
| −3 | K060975 | IF True Sine Interferential Stimulator / Model WL-2206A1 & WI-2206A2 | Theratech, Inc. | 2006 | — |
| −2 | K090023 | IF Series True Sine Interferential Stimulator, Model: WL-2206B and WL-2106E | Well-Life Healthcare Limited | 2009 | — |
| −1 | K092763 | IF True Sine Interferential Stimulator, WL-2206D | Well-Life Healthcare Limited | 2009 | — |
| 0 (this device) | K100399 | 4 Channels Multiple Model Digital Electrical Stimulator, Model Nuvostim IV… | Well-Life Healthcare Limited | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 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? (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 |
|---|---|---|---|
| * | K033857 | T-Tech Digital, Model WL-22XXA SeriesSummary page 1…4 Channels Multiple Modes Electrical Stimulator/ Model: NuvoStimn IV,WL-2504A 3. Information of the 510(k) Cleared Device (Predicate Device): WL-2203A (K033857), WL-2204A(K033857),WL-2204A -P2(K(033857), and WL-2206D(K092763) 4. Device Description: The Well-Life 4 Channe… | 2003 |
| * | K092763 | IF True Sine Interferential Stimulator, WL-2206DSummary page 1…n IV,WL-2504A 3. Information of the 510(k) Cleared Device (Predicate Device): WL-2203A (K033857), WL-2204A(K033857),WL-2204A -P2(K(033857), and WL-2206D(K092763) 4. Device Description: The Well-Life 4 Channels Multiple Modes Electrical Stimulator/ Model: WL-2504A is the… | 2009 |
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 18 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- None of the 12 ancestors has a recall.
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. 2010, this device’s year, is highlighted.
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 indication for use of this device includes the prescription TENS, NMS, Interferential stimulation as follows:
Transcutaneous Electrical Nerve Stimulator (TENS/IF TENS) & Program can be used
for the following applications :
For symptomatic relief of chronic intractable pain.
Neuromuscular electrical stimulation (NMS) & Program stimulation can be
used for the following applications:
* Relax muscle spasms
* Prevent or retard disuse atrophy
* Increase local blood circulation
* Re-educate muscles
* Maintain or increase the range of motion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100399 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100399: 4 Channels Multiple Model Digital Electrical Stimulator, Model Nuvostim IV, WL-2504A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100399
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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