510(k) · Cleared
ClearedIF Series True Sine Interferential Stimulator, Model: WL-2206B and WL-2106E
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Well-Life Healthcare Limited · LIH Interferential Current Therapy
Cleared on Jan 30, 2009 as substantially equivalent to K060975 (Theratech, Inc., 2006) after a 25-day review. Its family tree reaches back 5 generations to 1992. 2 later devices descend from it.
- Decided
- Jan 30, 2009
- Review
- 25 days
- Class
- Class II
- Product code
- LIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K921441 (1992). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK921441 Interferential Stimulator Model Inf 4150/aBiomedical Life Systems, Inc. · 1992
- 4 generations backK952683 Apex Medical Corp. Portable Interferential Stimulation DeviceWholesale Medical Imports, Inc. · 1997
- 3 generations backK024100 IF Series True Sine Interferential Stimulator/Model: WL-2206, Well…Theratech, Inc. · 2003
- 2 generations backK050847 IF True Sine Interferential Stimulator, Model WL-2206ATheratech, Inc. · 2005
- 1 generation backK060975 IF True Sine Interferential Stimulator / Model WL-2206A1 & WI-2206A2Theratech, Inc. · 2006
- This deviceK090023 IF Series True Sine Interferential Stimulator, Model: WL-2206B and…Well-Life Healthcare Limited · 2009
- Descendant · cites it directly · 1 of its ownK092763 IF True Sine Interferential Stimulator, WL-2206DWell-Life Healthcare Limited · 2009
- Descendant · 2 generations on · 0 of its ownK100399 4 Channels Multiple Model Digital Electrical Stimulator, Model…Well-Life Healthcare Limited · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921441 | Interferential Stimulator Model Inf 4150/a | Biomedical Life Systems, Inc. | 1992 | — |
| −4 | K952683 | Apex Medical Corp. Portable Interferential Stimulation Device | Wholesale Medical Imports, Inc. | 1997 | — |
| −3 | K024100 | IF Series True Sine Interferential Stimulator/Model: WL-2206, Well IF, Life IF… | Theratech, Inc. | 2003 | — |
| −2 | K050847 | IF True Sine Interferential Stimulator, Model WL-2206A | Theratech, Inc. | 2005 | — |
| −1 | K060975 | IF True Sine Interferential Stimulator / Model WL-2206A1 & WI-2206A2 | Theratech, Inc. | 2006 | — |
| 0 (this device) | 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 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 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 LIH? 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 LIH device
- #1 K231575 Vecttor VT-300score 7.1 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K060975 | IF True Sine Interferential Stimulator / Model WL-2206A1 & WI-2206A2Summary page 1…Device: IF series True sine interferential stimulator / Model: WL-2206B & WL-2106E. 3. Information of the 510(k) Cleared Device (Predicate Device): WL-2206A2 (K060975). 4. Device Description: The WL-2206B and WL-2106E are the device which generates the small true-sine pulses of electric… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092763 | IF True Sine Interferential Stimulator, WL-2206D | 2009 | 1 |
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 17 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K092763 (Well-Life Healthcare Limited, 2009) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LIH devicesLIH Interferential Current Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · LIH
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LIH
Too few LIH 510(k)s in any year since 2007 to give a median.
Recalls per year · LIH
No recall names LIH since 2007.
Adverse event reports per year · LIH
1in 2025
MAUDE reports naming product code LIH, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 14 |
| 2009 | 2 | — | 0 | 3 |
| 2010 | 2 | — | 0 | 2 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The device is an interferential stimulator with TENS indications used for
symptomatic relief and management of chronic intractable pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090023 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090023: IF Series True Sine Interferential Stimulator, Model: WL-2206B and WL-2106E.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090023
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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