510(k) · Cleared
ClearedE-Fit Infinity System (EF-2090 Controller and EF-100 Unit)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fit-Pro, Ltd. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Aug 25, 2021 as substantially equivalent to K133225 (Fit-Pro Kft, Ltd., 2014) after a 387-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it.
- Decided
- Aug 25, 2021
- Review
- 387 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K940301 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 2 generations backK011880 Compex SportCompex S.A. · 2002
- 1 generation backK133225 E-Fit EF-1280 Ems MachineFit-Pro Kft, Ltd. · 2014
- This deviceK202148 E-Fit Infinity System (EF-2090 Controller and EF-100 Unit)Fit-Pro, Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK260945 Ultima System (UL-800);Ultimate Face Package…Fit-Pro KFT (Ltd.) - DBA E-Fit · 2026
Most influential descendants
Showing 1 of 1 · See all- K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −2 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −1 | K133225 | E-Fit EF-1280 Ems Machine | Fit-Pro Kft, Ltd. | 2014 | — |
| 0 (this device) | K202148 | E-Fit Infinity System (EF-2090 Controller and EF-100 Unit) | Fit-Pro, Ltd. | 2021 | — |
| +1 | K260945 | Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape… | Fit-Pro KFT (Ltd.) - DBA E-Fit | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K133225 | E-Fit EF-1280 Ems MachineSummary page 4…gally marketed device: E-FIT EF-1280 EMS MACHINE Manufacturer: Fit-Pro Ltd. 510(k) number: K133225 Page 1 of 12 4. Descr… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260945 | Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension… | 2026 | 0 |
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 27 years and passes through 4 companies; a new generation was cleared every 7.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K260945 (Fit-Pro KFT (Ltd.) - DBA E-Fit, 2026) has gone furthest, with 0 descendants of its own.
- 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. 2021, 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 E-Fit Infinity System is designated to prescription use (Rx) only. E-Fit Infinity system (EF-2090 and EF-100) is a machine system with electronic muscle stimulation based on EMS technology. Regarding its use, the output power is limited and specifically designed as an addition to other sports and for toning muscles. It may only be used for healthy muscles and clients, and not to be used for rehabilitation purposes. The E-Fit Infinity system was…
Read the full statement (245 words)
The E-Fit Infinity System is designated to prescription use (Rx) only.
E-Fit Infinity system (EF-2090 and EF-100) is a machine system with electronic muscle stimulation based on EMS technology. Regarding its use, the output power is limited and specifically designed as an addition to other sports and for toning muscles. It may only be used for healthy muscles and clients, and not to be used for rehabilitation purposes.
The E-Fit Infinity system was designed to stimulate healthy muscles in order to improve or facilitate muscle performance. The E-Fit Infinity system must not be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the E-Fit Infinity system training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.
The E-Fit Infinity system's 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.
The various types of muscle work that the E-Fit Infinity system can impose on the stimulated muscles are able to improve or facilitate muscle performance. The E-Fit Infinity system may therefore be considered a technique of muscle training.
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/K202148 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202148: E-Fit Infinity System (EF-2090 Controller and EF-100 Unit).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202148
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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