510(k) · Cleared
ClearedEmpi Phoenix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Djo, LLC · IPF Stimulator, Muscle, Powered
Cleared on May 6, 2013 as substantially equivalent to K090632 (Chattanooga Group, 2009) and 1 other predicate after a 130-day review. Its family tree reaches back 4 generations to 1988. 25 later devices descend from it.
- Decided
- May 6, 2013
- Review
- 130 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K881114 (1988). 19 ancestors in all, the oldest K872976 (1987). 25 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK881114 Empi Model 989, TensEmpi · 1988
- 3 generations backK970203 Epix VTEmpi · 1997
- 2 generations backK061650 Select Tens, Model 4600SEmpi · 2007
- 1 generation backK093324 Empi ContinuumEmpi · 2010
- This deviceK124016 Empi PhoenixDjo, LLC · 2013
- Descendant · cites it directly · 24 of its ownK153704 StriveDjo, LLC · 2016
- Descendant · 2 generations on · 10 of its ownK170903 Compex Wireless USADjo, LLC · 2017
- Descendant · 2 generations on · 7 of its ownK182203 JKH Stimulator PlusJkh USA, LLC · 2019
- Descendant · 3 generations on · 4 of its ownK191151 JKH Stimulator PlusJkh USA, LLC · 2019
- Descendant · 2 generations on · 4 of its ownK170918 Compex Sport EliteDjo, LLC · 2017
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K153704StriveDjo, LLC · 2016 · cites it directly24descendants
- K170903Compex Wireless USADjo, LLC · 2017 · 2 generations on10descendants
- K182203JKH Stimulator PlusJkh USA, LLC · 2019 · 2 generations on7descendants
- K191151JKH Stimulator PlusJkh USA, LLC · 2019 · 3 generations on4descendants
- K170918Compex Sport EliteDjo, LLC · 2017 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K881114 | Empi Model 989, Tens | Empi | 1988 | — |
| −3 | K970203 | Epix VT | Empi | 1997 | — |
| −2 | K061650 | Select Tens, Model 4600S | Empi | 2007 | — |
| −1 | K093324 | Empi Continuum | Empi | 2010 | — |
| 0 (this device) | K124016 | Empi Phoenix | Djo, LLC | 2013 | — |
| +1 | K153704 | Strive | Djo, LLC | 2016 | — |
| +2 | K170903 | Compex Wireless USA | Djo, LLC | 2017 | — |
| +2 | K182203 | JKH Stimulator Plus | Jkh USA, LLC | 2019 | — |
| +3 | K191151 | JKH Stimulator Plus | Jkh USA, LLC | 2019 | — |
| +2 | K170918 | Compex Sport Elite | Djo, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 5 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 IPF? 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 IPF device
- #1 K241433 EVE Synergy (EVE-20M)score 19.6 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K090632 | Compex RehabSummary page 1…NYN, Stimulator, electrical, transcutaneous, for arthritis Regulatory Class: Class 11 Predicate Device(s): Compex® Rehab (K090632) EMPI Continuum (K093324) Abbreviated 510(k): New Device00 EMPI PHOENIX… | 2009 |
| * | K093324 | Empi ContinuumSummary page 1…thritis Regulatory Class: Class 11 Predicate Device(s): Compex® Rehab (K090632) EMPI Continuum (K093324) Abbreviated 510(k): New Device00 EMPI PHOENIX… | 2010 |
What descends from it? (25)
See all 251 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153704 | Strive | 2016 | 24 |
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 25 years and passes through 2 companies; a new generation was cleared every 9.0 years on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K153704 (Djo, LLC, 2016) has gone furthest, with 24 descendants of its own.
- 2 other devices also cite its predicate K090632.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · IPF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IPF
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IPF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IPF
8in 2025
MAUDE reports naming product code IPF, 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 | 8 | 143 | 0 | 11 |
| 2008 | 6 | 140 | 1 | 213 |
| 2009 | 7 | 216 | 0 | 150 |
| 2010 | 4 | 121 | 0 | 14 |
| 2011 | 4 | 275 | 1 | 25 |
| 2012 | 4 | 269 | 3 | 16 |
| 2013 | 10 | 180 | 0 | 6 |
| 2014 | 4 | 264 | 0 | 19 |
| 2015 | 3 | 43 | 0 | 11 |
| 2016 | 7 | 113 | 0 | 8 |
| 2017 | 5 | 110 | 0 | 2 |
| 2018 | 5 | 73 | 0 | 3 |
| 2019 | 4 | 133 | 0 | 10 |
| 2020 | 9 | 121 | 0 | 13 |
| 2021 | 15 | 98 | 0 | 3 |
| 2022 | 7 | 108 | 0 | 4 |
| 2023 | 9 | 255 | 1 | 8 |
| 2024 | 7 | 201 | 0 | 5 |
| 2025 | 3 | 257 | 0 | 8 |
| 2026 | 3 | 206 | 0 | — |
What is it indicated for?
The Empi Phoenix is a multifunctional electrotherapy device with various treatment modes that allow for neuromuIscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS) and pulsed current stimulation (PCs). As an NMWES device, indicationsarefor the followving conditions: - Retarding or preventing disuse atrophy - Maintaining or increasing range of motion - Re-educating muscles - Relaxation of muscle spasms - Increasing…
Read the full statement (149 words)
The Empi Phoenix is a multifunctional electrotherapy device with various treatment modes that allow for neuromuIscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS) and pulsed current stimulation (PCs).
As an NMWES device, indicationsarefor the followving conditions:
- Retarding or preventing disuse atrophy
- Maintaining or increasing range of motion
- Re-educating muscles
- Relaxation of muscle spasms
- Increasing local blood circulation
As a TENS device, indications arefor the followving conditions:
- Symptomatic relief and management of chronic, intractable pain
- Adjunctive treatment for post-surgical and post-trauma acute pain
- Relief of pain associated with arthritis
As a pulsed current device, indications arefor the fod/owing conditions:
- Reduction of edema (under negative electrode)
- Reduction of muscle spasm
- Influencing local blood circulation (under negative electrode)
- Retardation or prevention of disuse atrophy
- Facilitation of voluntary motor function
- Maintenance of increase of range of motion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K124016 · printed Nov 6, 2026
Cite this page
510(k) Report. “K124016: Empi Phoenix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K124016
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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