510(k) · Cleared
ClearedZionic Pro Max (EMS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Termosalud S.L. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Mar 12, 2026 as substantially equivalent to K201653 (Djo, LLC, 2020) after a 113-day review. Its family tree reaches back 8 generations to 1988.
- Decided
- Mar 12, 2026
- Review
- 113 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K881114 (1988). 32 ancestors in all, the oldest K872976 (1987). No later device cites it as a predicate yet.
- Root · 8 generations backK881114 Empi Model 989, TensEmpi · 1988
- 7 generations backK970203 Epix VTEmpi · 1997
- 6 generations backK061650 Select Tens, Model 4600SEmpi · 2007
- 5 generations backK093324 Empi ContinuumEmpi · 2010
- 4 generations backK124016 Empi PhoenixDjo, LLC · 2013
- 3 generations backK153704 StriveDjo, LLC · 2016
- 2 generations backK170918 Compex Sport EliteDjo, LLC · 2017
- 1 generation backK201653 Compex Sport Elite 3.0Djo, LLC · 2020
- This deviceK253636 Zionic Pro Max (EMS)Termosalud S.L. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K881114 | Empi Model 989, Tens | Empi | 1988 | — |
| −7 | K970203 | Epix VT | Empi | 1997 | — |
| −6 | K061650 | Select Tens, Model 4600S | Empi | 2007 | — |
| −5 | K093324 | Empi Continuum | Empi | 2010 | — |
| −4 | K124016 | Empi Phoenix | Djo, LLC | 2013 | — |
| −3 | K153704 | Strive | Djo, LLC | 2016 | — |
| −2 | K170918 | Compex Sport Elite | Djo, LLC | 2017 | — |
| −1 | K201653 | Compex Sport Elite 3.0 | Djo, LLC | 2020 | — |
| 0 (this device) | K253636 | Zionic Pro Max (EMS) | Termosalud S.L. | 2026 | — |
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 |
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 |
|---|---|---|---|
| * | K201653 | Compex Sport Elite 3.0Summary page 5…NGX Regulatory Class II Legally Marketed Predicate Device Compex Sport Elite 3.0 K201653 Device Description: The ZIONIC Pro Max is an innovative electrical impulse generator that generates electrical muscle stimulatio… | 2020 |
| † | K940301 | Compex 2 | 1994 |
| † | K011880 | Compex Sport | 2002 |
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 38 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 32 ancestors has a recall of any class.
- 1 other device also cites its predicate K201653.
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. 2026, 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?
The Zionic Pro Max EMS function of the device is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The work imposed on the muscles by the Zionic Pro Max programs is not suitable for rehabilitation or physiotherapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253636 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253636: Zionic Pro Max (EMS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253636
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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