510(k) · Cleared
ClearedXBody Go USA, XBody Pro USA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xbody Hungary Kft. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on May 30, 2025 as substantially equivalent to K221200 (Xbody Hungary Kft., 2023) after a 248-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- May 30, 2025
- Review
- 248 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K940301 (1994). No later device cites it as a predicate yet.
- Root · 5 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 4 generations backK011880 Compex SportCompex S.A. · 2002
- 3 generations backK133225 E-Fit EF-1280 Ems MachineFit-Pro Kft, Ltd. · 2014
- 2 generations backK190038 Xbody Newave USAXbody Hungary Kft. · 2019
- 1 generation backK221200 XBody Go USA, XBody Pro USAXbody Hungary Kft. · 2023
- This deviceK242926 XBody Go USA, XBody Pro USAXbody Hungary Kft. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −4 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −3 | K133225 | E-Fit EF-1280 Ems Machine | Fit-Pro Kft, Ltd. | 2014 | — |
| −2 | K190038 | Xbody Newave USA | Xbody Hungary Kft. | 2019 | — |
| −1 | K221200 | XBody Go USA, XBody Pro USA | Xbody Hungary Kft. | 2023 | — |
| 0 (this device) | K242926 | XBody Go USA, XBody Pro USA | Xbody Hungary Kft. | 2025 | — |
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 |
|---|---|---|---|
| * | K221200 | XBody Go USA, XBody Pro USASummary page 5…te Device Predicate Device: XBody Go USA, XBody Pro USA Manufacturer: XBody Hungary Kft Predicate 510(k) Number: K221200 1 XBody Hungary Kft.… | 2023 |
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 4 companies; a new generation was cleared every 4.4 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K221200.
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. 2025, 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 XBODY Go USA and XBODY Pro USA are machines with electronic muscle stimulation based on EMS technology. The devices are specifically designed as an addition to other sports and for training muscles. They must be used only for healthy muscles and clients, not for rehabilitation purposes. Both models are intended to stimulate healthy muscles in order to improve or facilitate muscle performance. Neither model is intended to be used in conjunction with…
Read the full statement (226 words)
The XBODY Go USA and XBODY Pro USA are machines with electronic muscle stimulation based
on EMS technology. The devices are specifically designed as an addition to other sports and for
training muscles. They must be used only for healthy muscles and clients, not for rehabilitation
purposes.
Both models are intended to stimulate healthy muscles in order to improve or facilitate muscle
performance. Neither model is intended to be used in conjunction with therapy or treatment of
medical diseases or medical conditions of any kind. None of the XBODY Go USA or XBODY Pro
USA training programs are designed for injured or ailing muscles and their use on such muscles is
contraindicated.
For both models, electrical impulses allow the triggering of action potentials on motoneurons of
motor nerves (excitations). These excitations of motoneurons 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 XBODY Go USA and XBODY Pro USA can impose on
the stimulated muscles are able to improve or facilitate muscle performance. Both models 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/K242926 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242926: XBody Go USA, XBody Pro USA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242926
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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