510(k) · Cleared
ClearedInfinity Electrotherapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Empi · LIH Interferential Current Therapy
Cleared on Dec 17, 2004 as substantially equivalent to K021100 (Empi, 2002) and 1 other predicate after a 140-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Dec 17, 2004
- Review
- 140 days
- Class
- Class II
- Product code
- LIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K931781 (1993). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931781 | Jace Tri-Stim Device | Jace Systems, Inc. | 1993 | — |
| −1 | K021100 | 300 PV Complete Electrotherapy System | Empi | 2002 | — |
| 0 (this device) | K042057 | Infinity Electrotherapy System | Empi | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K021100 | 300 PV Complete Electrotherapy SystemSummary page 1…mes: Powered Muscle Stimulator, Interferential Current Stimulator 3. PREDICATE DEVICES Empi 300 PV K(021100 Ryan Telemedicine K030254 4. INTENDED USE The Infinity is a multi-function electrotherapy device… | 2002 |
| * | K030254 | Interferential Stimulator, Model RTM1000Summary page 1…ential Current Stimulator 3. PREDICATE DEVICES Empi 300 PV K(021100 Ryan Telemedicine K030254 4. INTENDED USE The Infinity is a multi-function electrotherapy device with various treatment modes that allo… | 2003 |
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 11 years and passes through 2 companies; a new generation was cleared every 8.7 years on median.
- None of the 5 ancestors has a recall.
- 9 other devices also cite its predicate K021100.
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 Infinity is a multi-function electrotherapy device with various treatment modes that
allow for conventional interferential and premodulated interferential current stimulation
(IFS) and is indicated for the following conditions:
* Symptomatic relief of acute pain
* Symptomatic relief and management of chronic intractable pain
* Symptomatic relief for post-surgical and post-traumatic acute pain
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042057 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042057: Infinity Electrotherapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042057
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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