510(k) · Cleared
ClearedE-Fit EF-1280 Ems Machine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fit-Pro Kft, Ltd. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Oct 24, 2014 as substantially equivalent to K011880 (Compex S.A., 2002) after a 368-day review. Its family tree reaches back 2 generations to 1994. 19 later devices descend from it.
- Decided
- Oct 24, 2014
- Review
- 368 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K940301 (1994). 19 later devices descend from it, 7 citing it directly.
- Root · 2 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 1 generation backK011880 Compex SportCompex S.A. · 2002
- This deviceK133225 E-Fit EF-1280 Ems MachineFit-Pro Kft, Ltd. · 2014
- Descendant · cites it directly · 4 of its ownK190038 Xbody Newave USAXbody Hungary Kft. · 2019
- Descendant · 2 generations on · 3 of its ownK221200 XBody Go USA, XBody Pro USAXbody Hungary Kft. · 2023
- Descendant · cites it directly · 3 of its ownK182519 Miha Bodytec IIMiha Bodytec GmbH · 2019
- Descendant · cites it directly · 3 of its ownK181955 WiEMSproMedical Cables S.L. · 2019
- Descendant · 2 generations on · 2 of its ownK201975 miha bodytec IIMiha Bodytec GmbH · 2021
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K190038Xbody Newave USAXbody Hungary Kft. · 2019 · cites it directly4descendants
- K221200XBody Go USA, XBody Pro USAXbody Hungary Kft. · 2023 · 2 generations on3descendants
- K182519Miha Bodytec IIMiha Bodytec GmbH · 2019 · cites it directly3descendants
- K181955WiEMSproMedical Cables S.L. · 2019 · cites it directly3descendants
- K201975miha bodytec IIMiha Bodytec GmbH · 2021 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −1 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| 0 (this device) | K133225 | E-Fit EF-1280 Ems Machine | Fit-Pro Kft, Ltd. | 2014 | — |
| +1 | K190038 | Xbody Newave USA | Xbody Hungary Kft. | 2019 | — |
| +2 | K221200 | XBody Go USA, XBody Pro USA | Xbody Hungary Kft. | 2023 | — |
| +1 | K182519 | Miha Bodytec II | Miha Bodytec GmbH | 2019 | — |
| +1 | K181955 | WiEMSpro | Medical Cables S.L. | 2019 | — |
| +2 | K201975 | miha bodytec II | Miha Bodytec GmbH | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K011880 | Compex SportSummary page 4…predicate device has been identified: Name: Compex Sport Manufacturer: Compex S.A. K Number: K011880 E. Description of the Device E‐fit EF-1280 is a machine with electronic muscle stimulation based on EMS technology.… | 2002 |
What descends from it? (19)
See all 197 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190038 | Xbody Newave USA | 2019 | 4 |
| K182519 | Miha Bodytec II | 2019 | 3 |
| K181955 | WiEMSpro | 2019 | 3 |
| K202148 | E-Fit Infinity System (EF-2090 Controller and EF-100 Unit) | 2021 | 1 |
| K181199 | Katalyst Mark 1 Muscle Stimulation System Model 2 | 2018 | 1 |
| K181419 | Flix-Ems | 2019 | 0 |
| K171035 | Katalyst Mark 1 Muscle Stimulation System | 2017 | 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 20 years and passes through 3 companies; a new generation was cleared every 12.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K190038 (Xbody Hungary Kft., 2019) has gone furthest, with 4 descendants of its own.
- 11 other devices also cite its predicate K011880.
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. 2014, 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?
E‐Fit EF‐1280 is a machine with electronic muscle stimulation based on EMS technology. Regarding its use, the device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes.
The E‐Fit EF‐1280 intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The E‐Fit EF‐1280 is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the E‐Fit EF‐1280 training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.
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/K133225 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133225: E-Fit EF-1280 Ems Machine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133225
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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