510(k) · Cleared
ClearedGM3 Series IF Tens, Model GM3X2IF (Where X IS a Parameter of Different Housing)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gemore Technology Co, Ltd. · LIH Interferential Current Therapy
Cleared on Dec 10, 2003 as substantially equivalent to K930535 (Skylark Device Co., Ltd., 1994) and 1 other predicate after a 99-day review. Its family tree reaches back 2 generations to 1992. 7 later devices descend from it.
- Decided
- Dec 10, 2003
- Review
- 99 days
- Class
- Class II
- Product code
- LIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K921441 (1992). 3 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK921441 Interferential Stimulator Model Inf 4150/aBiomedical Life Systems, Inc. · 1992
- 1 generation backK952683 Apex Medical Corp. Portable Interferential Stimulation DeviceWholesale Medical Imports, Inc. · 1997
- This deviceK032719 GM3 Series IF Tens, Model GM3X2IF (Where X IS a Parameter of…Gemore Technology Co, Ltd. · 2003
- Descendant · cites it directly · 2 of its ownK120054 Ultima NeoPain Management Technologies · 2012
- Descendant · cites it directly · 2 of its ownK042559 Gem-Twin Tens/ Models GM3XY/ZGemore Technology Co, Ltd. · 2004
- Descendant · 2 generations on · 1 of its ownK232441 Unipro (K-UNIPRO-US)Tenscare, Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK252236 CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC · 2025
- Descendant · cites it directly · 0 of its ownK122944 Gemore True Sine Interferential StimulatorGemore Technology Co, Ltd. · 2012
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K120054Ultima NeoPain Management Technologies · 2012 · cites it directly2descendants
- K042559Gem-Twin Tens/ Models GM3XY/ZGemore Technology Co, Ltd. · 2004 · cites it directly2descendants
- K232441Unipro (K-UNIPRO-US)Tenscare, Ltd. · 2024 · 2 generations on1descendant
- K252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC · 2025 · 3 generations on0descendants
- K122944Gemore True Sine Interferential StimulatorGemore Technology Co, Ltd. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K921441 | Interferential Stimulator Model Inf 4150/a | Biomedical Life Systems, Inc. | 1992 | — |
| −1 | K952683 | Apex Medical Corp. Portable Interferential Stimulation Device | Wholesale Medical Imports, Inc. | 1997 | — |
| 0 (this device) | K032719 | GM3 Series IF Tens, Model GM3X2IF (Where X IS a Parameter of Different Housing) | Gemore Technology Co, Ltd. | 2003 | — |
| +1 | K120054 | Ultima Neo | Pain Management Technologies | 2012 | — |
| +1 | K042559 | Gem-Twin Tens/ Models GM3XY/Z | Gemore Technology Co, Ltd. | 2004 | — |
| +2 | K232441 | Unipro (K-UNIPRO-US) | Tenscare, Ltd. | 2024 | — |
| +3 | K252236 | CP Relief Wand Rx - TENS/NMES | N & C Holdings, LLC | 2025 | — |
| +1 | K122944 | Gemore True Sine Interferential Stimulator | Gemore Technology Co, Ltd. | 2012 | — |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K930535 | IF400Summary page 1…ferential stimulator I Model: GM3X2IF, where X is the parameter for different housing. 3. Information of the 510(k) Cleared Device (Predicate Device): IF-400 (k930535) and IF-4000 (k952683). 4. Device Description: The GM3X2IF is the device which generates the small real-sine pulses of ele… | 1994 |
| * | K952683 | Apex Medical Corp. Portable Interferential Stimulation DeviceSummary page 1…Model: GM3X2IF, where X is the parameter for different housing. 3. Information of the 510(k) Cleared Device (Predicate Device): IF-400 (k930535) and IF-4000 (k952683). 4. Device Description: The GM3X2IF is the device which generates the small real-sine pulses of electrical current. T… | 1997 |
What descends from it? (7)
3 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 11 years and passes through 3 companies; a new generation was cleared every 6.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K120054 (Pain Management Technologies, 2012) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K930535.
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/K032719 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032719: GM3 Series IF Tens, Model GM3X2IF (Where X IS a Parameter of Different Housing).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032719
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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