510(k) · Cleared
ClearedIF True Sine Interferential Stimulator, Model WL-2206A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theratech, Inc. · IPF Stimulator, Muscle, Powered
Cleared on Jun 17, 2005 as substantially equivalent to K024100 (Theratech, Inc., 2003) after a 74-day review. Its family tree reaches back 3 generations to 1992. 5 later devices descend from it.
- Decided
- Jun 17, 2005
- Review
- 74 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K921441 (1992). 4 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK921441 Interferential Stimulator Model Inf 4150/aBiomedical Life Systems, Inc. · 1992
- 2 generations backK952683 Apex Medical Corp. Portable Interferential Stimulation DeviceWholesale Medical Imports, Inc. · 1997
- 1 generation backK024100 IF Series True Sine Interferential Stimulator/Model: WL-2206, Well…Theratech, Inc. · 2003
- This deviceK050847 IF True Sine Interferential Stimulator, Model WL-2206ATheratech, Inc. · 2005
- Descendant · cites it directly · 3 of its ownK060975 IF True Sine Interferential Stimulator / Model WL-2206A1 & WI-2206A2Theratech, Inc. · 2006
- Descendant · 2 generations on · 2 of its ownK090023 IF Series True Sine Interferential Stimulator, Model: WL-2206B and…Well-Life Healthcare Limited · 2009
- Descendant · 3 generations on · 1 of its ownK092763 IF True Sine Interferential Stimulator, WL-2206DWell-Life Healthcare Limited · 2009
- Descendant · cites it directly · 0 of its ownK110509 Everyway Interferntial Stimulator, Model IF-908Everyway Medical Instruments Co.,Ltd · 2011
- Descendant · 4 generations on · 0 of its ownK100399 4 Channels Multiple Model Digital Electrical Stimulator, Model…Well-Life Healthcare Limited · 2010
Most influential descendants
Showing 5 of 5 · See all- K060975IF True Sine Interferential Stimulator / Model WL-2206A1 & WI-2206A2Theratech, Inc. · 2006 · cites it directly3descendants
- K090023IF Series True Sine Interferential Stimulator, Model: WL-2206B and WL-2106EWell-Life Healthcare Limited · 2009 · 2 generations on2descendants
- K092763IF True Sine Interferential Stimulator, WL-2206DWell-Life Healthcare Limited · 2009 · 3 generations on1descendant
- K110509Everyway Interferntial Stimulator, Model IF-908Everyway Medical Instruments Co.,Ltd · 2011 · cites it directly0descendants
- K1003994 Channels Multiple Model Digital Electrical Stimulator, Model Nuvostim IV, WL-2504AWell-Life Healthcare Limited · 2010 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921441 | Interferential Stimulator Model Inf 4150/a | Biomedical Life Systems, Inc. | 1992 | — |
| −2 | K952683 | Apex Medical Corp. Portable Interferential Stimulation Device | Wholesale Medical Imports, Inc. | 1997 | — |
| −1 | K024100 | IF Series True Sine Interferential Stimulator/Model: WL-2206, Well IF, Life IF… | Theratech, Inc. | 2003 | — |
| 0 (this device) | 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 | — |
| +2 | K090023 | IF Series True Sine Interferential Stimulator, Model: WL-2206B and WL-2106E | Well-Life Healthcare Limited | 2009 | — |
| +3 | K092763 | IF True Sine Interferential Stimulator, WL-2206D | Well-Life Healthcare Limited | 2009 | — |
| +1 | K110509 | Everyway Interferntial Stimulator, Model IF-908 | Everyway Medical Instruments Co.,Ltd | 2011 | — |
| +4 | 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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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 IPF? 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 IPF device
- #1 K241433 EVE Synergy (EVE-20M)score 19.6 · 25 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 |
|---|---|---|---|
| * | K024100 | IF Series True Sine Interferential Stimulator/Model: WL-2206, Well IF, Life IF and the…Summary page 2…The true sine interferential stimulator, model WL-2206A, has the same intended use and technological characteristics as the cleared device of WL-2206 (k024100). Moreover, verification and validation tests contained in this submission demonstrate that the di… | 2003 |
What descends from it? (5)
2 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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K060975 (Theratech, Inc., 2006) has gone furthest, with 3 descendants of its own.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IPF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IPF
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IPF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IPF
8in 2025
MAUDE reports naming product code IPF, 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 | 8 | 143 | 0 | 11 |
| 2008 | 6 | 140 | 1 | 213 |
| 2009 | 7 | 216 | 0 | 150 |
| 2010 | 4 | 121 | 0 | 14 |
| 2011 | 4 | 275 | 1 | 25 |
| 2012 | 4 | 269 | 3 | 16 |
| 2013 | 10 | 180 | 0 | 6 |
| 2014 | 4 | 264 | 0 | 19 |
| 2015 | 3 | 43 | 0 | 11 |
| 2016 | 7 | 113 | 0 | 8 |
| 2017 | 5 | 110 | 0 | 2 |
| 2018 | 5 | 73 | 0 | 3 |
| 2019 | 4 | 133 | 0 | 10 |
| 2020 | 9 | 121 | 0 | 13 |
| 2021 | 15 | 98 | 0 | 3 |
| 2022 | 7 | 108 | 0 | 4 |
| 2023 | 9 | 255 | 1 | 8 |
| 2024 | 7 | 201 | 0 | 5 |
| 2025 | 3 | 257 | 0 | 8 |
| 2026 | 3 | 206 | 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/K050847 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050847: IF True Sine Interferential Stimulator, Model WL-2206A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050847
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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