510(k) · Cleared
ClearedGnesis EMS Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Creative Fitness Developments S.L. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Jun 6, 2023 as substantially equivalent to K181955 (Medical Cables S.L., 2019) and 1 other predicate after a 126-day review. Its family tree reaches back 9 generations to 1988.
- Decided
- Jun 6, 2023
- Review
- 126 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K881114 (1988). 35 ancestors in all, the oldest K872976 (1987). No later device cites it as a predicate yet.
- Root · 9 generations backK881114 Empi Model 989, TensEmpi · 1988
- 5 generations between
- 3 generations backK170903 Compex Wireless USADjo, LLC · 2017
- 2 generations backK181955 WiEMSproMedical Cables S.L. · 2019
- 1 generation backK212413 I-MotionI-Motion Group Global Iberica S.L. · 2022
- This deviceK230261 Gnesis EMS PlusCreative Fitness Developments S.L. · 2023
Show all 9 generations
- Root · 9 generations backK881114 Empi Model 989, TensEmpi · 1988
- 8 generations backK970203 Epix VTEmpi · 1997
- 7 generations backK061650 Select Tens, Model 4600SEmpi · 2007
- 6 generations backK093324 Empi ContinuumEmpi · 2010
- 5 generations backK124016 Empi PhoenixDjo, LLC · 2013
- 4 generations backK153704 StriveDjo, LLC · 2016
- 3 generations backK170903 Compex Wireless USADjo, LLC · 2017
- 2 generations backK181955 WiEMSproMedical Cables S.L. · 2019
- 1 generation backK212413 I-MotionI-Motion Group Global Iberica S.L. · 2022
- This deviceK230261 Gnesis EMS PlusCreative Fitness Developments S.L. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K881114 | Empi Model 989, Tens | Empi | 1988 | — |
| −8 | K970203 | Epix VT | Empi | 1997 | — |
| −7 | K061650 | Select Tens, Model 4600S | Empi | 2007 | — |
| −6 | K093324 | Empi Continuum | Empi | 2010 | — |
| −5 | K124016 | Empi Phoenix | Djo, LLC | 2013 | — |
| −4 | K153704 | Strive | Djo, LLC | 2016 | — |
| −3 | K170903 | Compex Wireless USA | Djo, LLC | 2017 | — |
| −2 | K181955 | WiEMSpro | Medical Cables S.L. | 2019 | — |
| −1 | K212413 | I-Motion | I-Motion Group Global Iberica S.L. | 2022 | — |
| 0 (this device) | K230261 | Gnesis EMS Plus | Creative Fitness Developments S.L. | 2023 | — |
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 |
| 2014 | 1 | 0 |
| 2015 | 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? (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 |
|---|---|---|---|
| * | K181955 | WiEMSproSummary page 5…red muscle stimulator Regulatory Class: Class II Product Code: NGX 3. PREDICATE DEVICE Name & 510(k) Number: WIEMSpro, K181955 I-MOTION, K212413 Manufacturer Name: Medical Cables S.L.… | 2019 |
| * | K212413 | I-MotionSummary page 5…ss II Product Code: NGX 3. PREDICATE DEVICE Name & 510(k) Number: WIEMSpro, K181955 I-MOTION, K212413 Manufacturer Name: Medical Cables S.L. I-Motion Group Global Iberica S.L 4. D… | 2022 |
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 35 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 35 ancestors has a recall of any class.
- 2 other devices also cite its predicate K181955.
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. 2023, 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?
Gnesis EMS Plus is intended to stimulate healthy muscles in order to improve or facilitate muscle performance, is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of Gnesis EMS Plus training programs is designed for injured or ailing muscles and its use on such cases is contraindicated. Each of Gnesis EMS Plus training programs, depending on the parameters of the electrical…
Read the full statement (136 words)
Gnesis EMS Plus is intended to stimulate healthy muscles in order to improve or facilitate muscle performance, is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.
None of Gnesis EMS Plus training programs is designed for injured or ailing muscles and its use on such cases is contraindicated.
Each of Gnesis EMS Plus training programs, depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), is designed for a specific type of exercise.
Gnesis EMS Plus is a device for electronic muscle stimulation based on EMS technology.
Gnesis EMS Plus is specifically designed as an addition to other sports and for training muscles. It must be used only on healthy muscles, not for rehabilitation purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230261 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230261: Gnesis EMS Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230261
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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