510(k) · Cleared
ClearedApex Medical Corp. Portable Interferential Stimulation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wholesale Medical Imports, Inc. · LIH Interferential Current Therapy
Cleared on Apr 1, 1997 as substantially equivalent to K921441 (Biomedical Life Systems, Inc., 1992) after a 659-day review. Its family tree reaches back 1 generation to 1992. 33 later devices descend from it.
- Decided
- Apr 1, 1997
- Review
- 659 days
- Class
- Class II
- Product code
- LIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K921441 (1992). 33 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK921441 Interferential Stimulator Model Inf 4150/aBiomedical Life Systems, Inc. · 1992
- This deviceK952683 Apex Medical Corp. Portable Interferential Stimulation DeviceWholesale Medical Imports, Inc. · 1997
- Descendant · cites it directly · 14 of its ownK060246 InfrexJohari Digital Healthcare, Ltd. · 2006
- Descendant · 2 generations on · 11 of its ownK072123 Homewave Neuromodulations Pain Therapy DeviceBiowave Corporation · 2008
- Descendant · 3 generations on · 9 of its ownK161154 Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator…Spr Therapeutics, LLC · 2016
- Descendant · 4 generations on · 7 of its ownK170902 Sprint System, Single Procedure Kit, Sprint System with Pad II…Spr Therapeutics, LLC · 2017
- 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
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K060246InfrexJohari Digital Healthcare, Ltd. · 2006 · cites it directly14descendants
- K072123Homewave Neuromodulations Pain Therapy DeviceBiowave Corporation · 2008 · 2 generations on11descendants
- K161154Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and…Spr Therapeutics, LLC · 2016 · 3 generations on9descendants
- K170902Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit…Spr Therapeutics, LLC · 2017 · 4 generations on7descendants
- K032719GM3 Series IF Tens, Model GM3X2IF (Where X IS a Parameter of Different Housing)Gemore Technology Co, Ltd. · 2003 · cites it directly7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921441 | Interferential Stimulator Model Inf 4150/a | Biomedical Life Systems, Inc. | 1992 | — |
| 0 (this device) | K952683 | Apex Medical Corp. Portable Interferential Stimulation Device | Wholesale Medical Imports, Inc. | 1997 | — |
| +1 | K060246 | Infrex | Johari Digital Healthcare, Ltd. | 2006 | — |
| +2 | K072123 | Homewave Neuromodulations Pain Therapy Device | Biowave Corporation | 2008 | — |
| +3 | K161154 | Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and… | Spr Therapeutics, LLC | 2016 | — |
| +4 | K170902 | Sprint System, Single Procedure Kit, Sprint System with Pad II, Single… | Spr Therapeutics, LLC | 2017 | — |
| +1 | K032719 | GM3 Series IF Tens, Model GM3X2IF (Where X IS a Parameter of Different Housing) | Gemore Technology Co, Ltd. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K921441 | Interferential Stimulator Model Inf 4150/aSummary page 2…tage. Please refer to chart below: COMPARISON BETWEEN IF-4000 AND INF 4150/A BRAND NAME IF-4000 INF 4150/A MAKER APEX MEDICAL CORP. BIOMEDICAL LIFE SYSTEMS, INC. K952683 K921441 510(K) NUMBER CARRIER FREQUENCY 4000 Hz, fixed 4000 Hz, fixed DIFFERENCE 1-150 beats per second, | 1-150 beats per second,… | 1992 |
What descends from it? (33)
See all 337 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060246 | Infrex | 2006 | 14 |
| K032719 | GM3 Series IF Tens, Model GM3X2IF (Where X IS a Parameter of Different Housing) | 2003 | 7 |
| K024100 | IF Series True Sine Interferential Stimulator/Model: WL-2206, Well IF, Life IF and the… | 2003 | 6 |
| K092780 | Inf 4160 Plus, Model D-FJ31F | 2010 | 0 |
| K071869 | Tens/IF 14 | 2008 | 0 |
| K070890 | Everlife Interferential Current Therapy, Model IF-100507 | 2007 | 0 |
| K043407 | Inf 4160, Model D-FJ27F | 2005 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K060246 (Johari Digital Healthcare, Ltd., 2006) has gone furthest, with 14 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 | — |
What is it indicated for?
This device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic acute pain.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K952683 · printed Nov 6, 2026
Cite this page
510(k) Report. “K952683: Apex Medical Corp. Portable Interferential Stimulation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K952683
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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