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 Jan 31, 2023 as substantially equivalent to K190038 (Xbody Hungary Kft., 2019) after a 280-day review. Its family tree reaches back 4 generations to 1994. 3 later devices descend from it.
- Decided
- Jan 31, 2023
- Review
- 280 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K940301 (1994). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 3 generations backK011880 Compex SportCompex S.A. · 2002
- 2 generations backK133225 E-Fit EF-1280 Ems MachineFit-Pro Kft, Ltd. · 2014
- 1 generation backK190038 Xbody Newave USAXbody Hungary Kft. · 2019
- This deviceK221200 XBody Go USA, XBody Pro USAXbody Hungary Kft. · 2023
- Descendant · cites it directly · 1 of its ownK250146 SofWave SystemSofwave Medical, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK251746 Pure ImpactSofwave Medical, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK242926 XBody Go USA, XBody Pro USAXbody Hungary Kft. · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −3 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −2 | K133225 | E-Fit EF-1280 Ems Machine | Fit-Pro Kft, Ltd. | 2014 | — |
| −1 | K190038 | Xbody Newave USA | Xbody Hungary Kft. | 2019 | — |
| 0 (this device) | K221200 | XBody Go USA, XBody Pro USA | Xbody Hungary Kft. | 2023 | — |
| +1 | K250146 | SofWave System | Sofwave Medical, Ltd. | 2025 | — |
| +2 | K251746 | Pure Impact | Sofwave Medical, Ltd. | 2025 | — |
| +1 | K242926 | XBody Go USA, XBody Pro USA | Xbody Hungary Kft. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 3 | 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.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 29 years and passes through 4 companies; a new generation was cleared every 7.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K250146 (Sofwave Medical, Ltd., 2025) has gone furthest, with 1 descendant of its own.
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?
The XBODY Go USA and XBODY Pro USA is a machine with electronic muscle stimulation based on EMS technology. 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 XBODY Go USA and XBODY Pro USA is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The XBODY Go USA and XBODY Pro USA is…
Read the full statement (251 words)
The XBODY Go USA and XBODY Pro USA is a machine with electronic muscle stimulation based on EMS technology.
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 XBODY Go USA and XBODY Pro USA is intended to stimulate healthy muscles in order to improve or facilitate
muscle performance. The XBODY Go USA and XBODY Pro USA is not 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 and XBODY Pro USA
training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.
The XBODY Go USA and XBODY Pro USA 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. The XBODY Go USA and XBODY Pro USA may
therefore be considered a technique of muscle training.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221200 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221200: 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/K221200
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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