510(k) · Cleared
ClearedEmpi Continuum
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Empi · IPF Stimulator, Muscle, Powered
Cleared on Mar 5, 2010 as substantially equivalent to K021100 (Empi, 2002) and 2 other predicates after a 133-day review. Its family tree reaches back 3 generations to 1988. 26 later devices descend from it.
- Decided
- Mar 5, 2010
- Review
- 133 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K881114 (1988). 15 ancestors in all, the oldest K872976 (1987). 26 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK881114 Empi Model 989, TensEmpi · 1988
- 2 generations backK970203 Epix VTEmpi · 1997
- 1 generation backK061650 Select Tens, Model 4600SEmpi · 2007
- This deviceK093324 Empi ContinuumEmpi · 2010
- Descendant · cites it directly · 25 of its ownK124016 Empi PhoenixDjo, LLC · 2013
- Descendant · 2 generations on · 24 of its ownK153704 StriveDjo, LLC · 2016
- Descendant · 3 generations on · 10 of its ownK170903 Compex Wireless USADjo, LLC · 2017
- Descendant · 3 generations on · 7 of its ownK182203 JKH Stimulator PlusJkh USA, LLC · 2019
- Descendant · 4 generations on · 4 of its ownK191151 JKH Stimulator PlusJkh USA, LLC · 2019
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K124016Empi PhoenixDjo, LLC · 2013 · cites it directly25descendants
- K153704StriveDjo, LLC · 2016 · 2 generations on24descendants
- K170903Compex Wireless USADjo, LLC · 2017 · 3 generations on10descendants
- K182203JKH Stimulator PlusJkh USA, LLC · 2019 · 3 generations on7descendants
- K191151JKH Stimulator PlusJkh USA, LLC · 2019 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K881114 | Empi Model 989, Tens | Empi | 1988 | — |
| −2 | K970203 | Epix VT | Empi | 1997 | — |
| −1 | K061650 | Select Tens, Model 4600S | Empi | 2007 | — |
| 0 (this device) | K093324 | Empi Continuum | Empi | 2010 | — |
| +1 | K124016 | Empi Phoenix | Djo, LLC | 2013 | — |
| +2 | K153704 | Strive | Djo, LLC | 2016 | — |
| +3 | K170903 | Compex Wireless USA | Djo, LLC | 2017 | — |
| +3 | K182203 | JKH Stimulator Plus | Jkh USA, LLC | 2019 | — |
| +4 | K191151 | JKH Stimulator Plus | Jkh USA, LLC | 2019 | — |
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 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 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 19.7 · 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? (3)
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 2…nt's GAIT. Substantially Equivalent Predicate Devices Predicate device(s): 300PV Complete Electrotherapy System 510(k) number: K(021100 Date: June 18, 2002 Additional Predicate Devices: Predicate device(s):… | 2002 |
| * | K061650 | Select Tens, Model 4600SSummary page 2…June 18, 2002 Additional Predicate Devices: Predicate device(s): Empi SELECT TENS System 510(k) number: K(061650 Date: February 22, 2007 Predicate device(s): REHABILICARE IF3 WAVE INTERFEREN… | 2007 |
| * | K050046 | Rehabilicare IF 3 Wave Interferential Stimulator System, Model 7110SSummary page 2…Predicate device(s): REHABILICARE IF3 WAVE INTERFERENTIAL STIMULATOR SYSTEM 510(k) number: K(050046 Date: April 13, 2005 Declarations of Conformity The Empi Continuum devic… | 2005 |
What descends from it? (26)
See all 261 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K124016 | Empi Phoenix | 2013 | 25 |
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 22 years and passes through 1 company; a new generation was cleared every 9.0 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K124016 (Djo, LLC, 2013) has gone furthest, with 25 descendants of its own.
- 9 other devices also cite its predicate K021100.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
As an NMES device, indications are for the following conditions: - Retarding or preventing disuse atrophy - Maintaining or increasing range of motion - Re-educating muscles - Relaxation of muscle spasms - Increasing local blood circulation * Prevention of venous thrombosis of the calf muscles immediately after surgery As a TENS device, indications are for the following conditions: * Symptomatic relief and managernent of chronic, intractable pain *…
Read the full statement (167 words)
As an NMES device, indications are for the following conditions:
- Retarding or preventing disuse atrophy
- Maintaining or increasing range of motion
- Re-educating muscles
- Relaxation of muscle spasms
- Increasing local blood circulation
* Prevention of venous thrombosis of the calf muscles immediately after surgery
As a TENS device, indications are for the following conditions:
* Symptomatic relief and managernent 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 are for the following 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
As an FES device, the indications for tlie.following condition:
*Stimulation of the leg and ankle muscles of partially paralyzed patients to provide flexation of the foot, thus improving the patient's GAIT.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093324 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093324: Empi Continuum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093324
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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