510(k) · Cleared
ClearedCompex Sport Elite 3.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Djo, LLC · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Nov 27, 2020 as substantially equivalent to K170918 (Djo, LLC, 2017) after a 162-day review. Its family tree reaches back 7 generations to 1988. 2 later devices descend from it.
- Decided
- Nov 27, 2020
- Review
- 162 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K881114 (1988). 31 ancestors in all, the oldest K872976 (1987). 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK881114 Empi Model 989, TensEmpi · 1988
- 6 generations backK970203 Epix VTEmpi · 1997
- 5 generations backK061650 Select Tens, Model 4600SEmpi · 2007
- 4 generations backK093324 Empi ContinuumEmpi · 2010
- 3 generations backK124016 Empi PhoenixDjo, LLC · 2013
- 2 generations backK153704 StriveDjo, LLC · 2016
- 1 generation backK170918 Compex Sport EliteDjo, LLC · 2017
- This deviceK201653 Compex Sport Elite 3.0Djo, LLC · 2020
- Descendant · cites it directly · 0 of its ownK253636 Zionic Pro Max (EMS)Termosalud S.L. · 2026
- Descendant · cites it directly · 0 of its ownK252154 Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME…Guangzhou Longest Medical Technology Co., Ltd. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K881114 | Empi Model 989, Tens | Empi | 1988 | — |
| −6 | K970203 | Epix VT | Empi | 1997 | — |
| −5 | K061650 | Select Tens, Model 4600S | Empi | 2007 | — |
| −4 | K093324 | Empi Continuum | Empi | 2010 | — |
| −3 | K124016 | Empi Phoenix | Djo, LLC | 2013 | — |
| −2 | K153704 | Strive | Djo, LLC | 2016 | — |
| −1 | K170918 | Compex Sport Elite | Djo, LLC | 2017 | — |
| 0 (this device) | K201653 | Compex Sport Elite 3.0 | Djo, LLC | 2020 | — |
| +1 | K253636 | Zionic Pro Max (EMS) | Termosalud S.L. | 2026 | — |
| +1 | K252154 | Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and… | Guangzhou Longest Medical Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 3 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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 NGX? 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 NGX device
- #1 K250146 SofWave Systemscore 15.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K170918 | Compex Sport EliteSummary page 4…Code NYN (subsequent code); Review Panel: Neurology Regulatory Class: Class II Predicate Device: Compex Sport Elite (K170918) - ClassII (Manufacturer’s own predicate device)… | 2017 |
What descends from it? (2)
2 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 32 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 31 ancestors has a recall of any class.
- Of its descendants, K253636 (Termosalud S.L., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K170918.
How does its category compare?
All NGX devicesNGX Stimulator, Muscle, Powered, For Muscle Conditioning: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · NGX
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NGX
93in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NGX
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NGX
15in 2025
MAUDE reports naming product code NGX, 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 | 7 | 135 | 0 | 0 |
| 2008 | 3 | 209 | 0 | 0 |
| 2009 | 4 | 132 | 0 | 0 |
| 2010 | 6 | 180 | 0 | 0 |
| 2011 | 5 | 291 | 0 | 1 |
| 2012 | 3 | 362 | 0 | 0 |
| 2013 | 6 | 269 | 2 | 1 |
| 2014 | 6 | 298 | 0 | 0 |
| 2015 | 9 | 184 | 0 | 7 |
| 2016 | 4 | 240 | 0 | 21 |
| 2017 | 10 | 108 | 0 | 2 |
| 2018 | 6 | 104 | 0 | 6 |
| 2019 | 14 | 167 | 0 | 4 |
| 2020 | 11 | 207 | 0 | 7 |
| 2021 | 12 | 256 | 0 | 5 |
| 2022 | 6 | 307 | 0 | 7 |
| 2023 | 12 | 96 | 0 | 8 |
| 2024 | 12 | 207 | 0 | 11 |
| 2025 | 15 | 93 | 0 | 15 |
| 2026 | 4 | 118 | 0 | — |
What is it indicated for?
EMS: The Compex Sport Elite 3.0 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The work imposed on the muscles by the Compex Sport Elite 3.0 programs is not suitable for rehabilitation or physiotherapy.
TENS: The Compex Sport Elite 3.0 TENS is intended for:
- Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities;
- The symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
The Compex Sport Elite 3.0 is an Over-the-Counter device to be used by adults only.
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/K201653 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201653: Compex Sport Elite 3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201653
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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