510(k) · Cleared
ClearedIF400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Skylark Device Co., Ltd. · LIH Interferential Current Therapy
Cleared on Jun 14, 1994 after a 497-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 15 later devices descend from it.
- Decided
- Jun 14, 1994
- Review
- 497 days
- Class
- Class II
- Product code
- LIH
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 2 citing it directly.
- This deviceK930535 IF400Skylark Device Co., Ltd. · 1994
- Descendant · cites it directly · 7 of its ownK032719 GM3 Series IF Tens, Model GM3X2IF (Where X IS a Parameter of…Gemore Technology Co, Ltd. · 2003
- Descendant · cites it directly · 6 of its ownK024100 IF Series True Sine Interferential Stimulator/Model: WL-2206, Well…Theratech, Inc. · 2003
- Descendant · 2 generations on · 5 of its ownK050847 IF True Sine Interferential Stimulator, Model WL-2206ATheratech, Inc. · 2005
- Descendant · 3 generations on · 3 of its ownK060975 IF True Sine Interferential Stimulator / Model WL-2206A1 & WI-2206A2Theratech, Inc. · 2006
- Descendant · 2 generations on · 2 of its ownK120054 Ultima NeoPain Management Technologies · 2012
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K032719GM3 Series IF Tens, Model GM3X2IF (Where X IS a Parameter of Different Housing)Gemore Technology Co, Ltd. · 2003 · cites it directly7descendants
- K024100IF Series True Sine Interferential Stimulator/Model: WL-2206, Well IF, Life IF and the…Theratech, Inc. · 2003 · cites it directly6descendants
- K050847IF True Sine Interferential Stimulator, Model WL-2206ATheratech, Inc. · 2005 · 2 generations on5descendants
- K060975IF True Sine Interferential Stimulator / Model WL-2206A1 & WI-2206A2Theratech, Inc. · 2006 · 3 generations on3descendants
- K120054Ultima NeoPain Management Technologies · 2012 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K930535 | IF400 | Skylark Device Co., Ltd. | 1994 | — |
| +1 | K032719 | GM3 Series IF Tens, Model GM3X2IF (Where X IS a Parameter of Different Housing) | Gemore Technology Co, Ltd. | 2003 | — |
| +1 | 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 | — |
| +3 | K060975 | IF True Sine Interferential Stimulator / Model WL-2206A1 & WI-2206A2 | Theratech, Inc. | 2006 | — |
| +2 | K120054 | Ultima Neo | Pain Management Technologies | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (15)
See all 152 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?
- Of its descendants, K032719 (Gemore Technology Co, Ltd., 2003) has gone furthest, with 7 descendants 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.
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 | — |
https://510kreport.com/device/K930535 · printed Nov 6, 2026
Cite this page
510(k) Report. “K930535: IF400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930535
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026