510(k) · Cleared
ClearedEveryway Interferntial Stimulator, Model IF-908
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Everyway Medical Instruments Co.,Ltd · LIH Interferential Current Therapy
Cleared on Jun 20, 2011 as substantially equivalent to K050847 (Theratech, Inc., 2005) after a 118-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Jun 20, 2011
- Review
- 118 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. No later device cites it as a predicate yet.
- 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 deviceK110509 Everyway Interferntial Stimulator, Model IF-908Everyway Medical Instruments Co.,Ltd · 2011
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) | K110509 | Everyway Interferntial Stimulator, Model IF-908 | Everyway Medical Instruments Co.,Ltd | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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…ial Stimulator, model IF-908. 3. Information of the 51 0(k) Cleared Device (Predicate Device): Theratech IFseries True sine interferential stimulator, model WL-2206A(K050847). 4. Classification Information: Trade/Device Name: Everyway Interferential Stimulator, model IF-908. Regulation Number: U… | 2005 |
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 19 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
- None of the 5 ancestors has a recall.
- 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. 2011, 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. It is intended for use on the order of a physician only
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110509 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110509: Everyway Interferntial Stimulator, Model IF-908.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110509
Report an extraction error
Are you the manufacturer?
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