510(k) · Cleared
ClearedFlix-Ems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Casgarum Investment, S.L. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on May 14, 2019 as substantially equivalent to K133225 (Fit-Pro Kft, Ltd., 2014) and 1 other predicate after a 348-day review. Its family tree reaches back 7 generations to 1988.
- Decided
- May 14, 2019
- Review
- 348 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K881114 (1988). 33 ancestors in all, the oldest K872976 (1987). No later device cites it as a predicate yet.
- 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 backK170903 Compex Wireless USADjo, LLC · 2017
- This deviceK181419 Flix-EmsCasgarum Investment, S.L. · 2019
View 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 | K170903 | Compex Wireless USA | Djo, LLC | 2017 | — |
| 0 (this device) | K181419 | Flix-Ems | Casgarum Investment, S.L. | 2019 | — |
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 |
|---|---|---|---|
| * | K133225 | E-Fit EF-1280 Ems MachineSummary page 4…: Stimulator, muscle, powered, for muscle conditioning (21 CFR 890.5850) PREDICATE DEVICE(S): E-Fit EF-1280 (K133225) Compex Wireless USA (K170903) DEVICE DESCRIPTION: The proposed device is an electro-medical d… | 2014 |
| * | K170903 | Compex Wireless USASummary page 4…ing (21 CFR 890.5850) PREDICATE DEVICE(S): E-Fit EF-1280 (K133225) Compex Wireless USA (K170903) DEVICE DESCRIPTION: The proposed device is an electro-medical device designed and manufactured for sports and fitness activity… | 2017 |
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 31 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 33 ancestors has a recall of any class.
- 6 other devices also cite its predicate K133225.
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. 2019, 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?
FLIX-EMS device is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only. FLIX-EMS is not intended for adjunctive therapy in the treatment of medical diseases and conditions of any kind. None of the FLIX-EMS stimulation programs are designed for injured or disease afflicted muscles. Its use on such muscles is contraindicated. The work imposed on the muscles by the FLIX-EMS programs is…
Read the full statement (153 words)
FLIX-EMS device is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.
FLIX-EMS is not intended for adjunctive therapy in the treatment of medical diseases and conditions of any kind. None of the FLIX-EMS stimulation programs are designed for injured or disease afflicted muscles. Its use on such muscles is contraindicated. The work imposed on the muscles by the FLIX-EMS programs is definitely not suitable for rehabilitation and physiotherapy.
FLIX-EMS electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles
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/K181419 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181419: Flix-Ems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181419
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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