510(k) · Cleared
ClearedIF True Sine Interferential Stimulator / Model WL-2206A1 & WI-2206A2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theratech, Inc. · LIH Interferential Current Therapy
Cleared on May 10, 2006 as substantially equivalent to K050847 (Theratech, Inc., 2005) after a 30-day review. Its family tree reaches back 4 generations to 1992. 3 later devices descend from it.
- Decided
- May 10, 2006
- Review
- 30 days
- Class
- Class II
- Product code
- LIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K921441 (1992). 5 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK921441 Interferential Stimulator Model Inf 4150/aBiomedical Life Systems, Inc. · 1992
- 3 generations backK952683 Apex Medical Corp. Portable Interferential Stimulation DeviceWholesale Medical Imports, Inc. · 1997
- 2 generations backK024100 IF Series True Sine Interferential Stimulator/Model: WL-2206, Well…Theratech, Inc. · 2003
- 1 generation backK050847 IF True Sine Interferential Stimulator, Model WL-2206ATheratech, Inc. · 2005
- This deviceK060975 IF True Sine Interferential Stimulator / Model WL-2206A1 & WI-2206A2Theratech, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK090023 IF Series True Sine Interferential Stimulator, Model: WL-2206B and…Well-Life Healthcare Limited · 2009
- Descendant · 2 generations on · 1 of its ownK092763 IF True Sine Interferential Stimulator, WL-2206DWell-Life Healthcare Limited · 2009
- Descendant · 3 generations on · 0 of its ownK100399 4 Channels Multiple Model Digital Electrical Stimulator, Model…Well-Life Healthcare Limited · 2010
Most influential descendants
Showing 3 of 3 · See all- K090023IF Series True Sine Interferential Stimulator, Model: WL-2206B and WL-2106EWell-Life Healthcare Limited · 2009 · cites it directly2descendants
- K092763IF True Sine Interferential Stimulator, WL-2206DWell-Life Healthcare Limited · 2009 · 2 generations on1descendant
- K1003994 Channels Multiple Model Digital Electrical Stimulator, Model Nuvostim IV, WL-2504AWell-Life Healthcare Limited · 2010 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K921441 | Interferential Stimulator Model Inf 4150/a | Biomedical Life Systems, Inc. | 1992 | — |
| −3 | K952683 | Apex Medical Corp. Portable Interferential Stimulation Device | Wholesale Medical Imports, Inc. | 1997 | — |
| −2 | K024100 | IF Series True Sine Interferential Stimulator/Model: WL-2206, Well IF, Life IF… | Theratech, Inc. | 2003 | — |
| −1 | K050847 | IF True Sine Interferential Stimulator, Model WL-2206A | Theratech, Inc. | 2005 | — |
| 0 (this device) | K060975 | IF True Sine Interferential Stimulator / Model WL-2206A1 & WI-2206A2 | Theratech, Inc. | 2006 | — |
| +1 | K090023 | IF Series True Sine Interferential Stimulator, Model: WL-2206B and WL-2106E | Well-Life Healthcare Limited | 2009 | — |
| +2 | K092763 | IF True Sine Interferential Stimulator, WL-2206D | Well-Life Healthcare Limited | 2009 | — |
| +3 | 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 | 2 | 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 |
|---|---|---|---|
| * | K050847 | IF True Sine Interferential Stimulator, Model WL-2206ASummary page 1…Device: IF series True sine interferential stimulator I Model: WL-2206A1 & WL-2206A2. 3. Information of the 510(k) Cleared Device (Predicate Device): WL-2206A (k050847). 4. Device Description: The WIL-2206A1 and WL-2206A2 are the device which generates the small true-sine pulses of electr… | 2005 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090023 | IF Series True Sine Interferential Stimulator, Model: WL-2206B and WL-2106E | 2009 | 2 |
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 14 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K090023 (Well-Life Healthcare Limited, 2009) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K050847.
How does its category compare?
All LIH devicesLIH Interferential Current Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years.
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/K060975 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060975: IF True Sine Interferential Stimulator / Model WL-2206A1 & WI-2206A2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060975
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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