510(k) · Cleared
ClearedXbody Newave 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 Apr 5, 2019 as substantially equivalent to K133225 (Fit-Pro Kft, Ltd., 2014) after an 87-day review. Its family tree reaches back 3 generations to 1994. 4 later devices descend from it.
- Decided
- Apr 5, 2019
- Review
- 87 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K940301 (1994). 4 later devices descend 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 deviceK190038 Xbody Newave USAXbody Hungary Kft. · 2019
- Descendant · cites it directly · 3 of its ownK221200 XBody Go USA, XBody Pro USAXbody Hungary Kft. · 2023
- Descendant · 2 generations on · 1 of its ownK250146 SofWave SystemSofwave Medical, Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK251746 Pure ImpactSofwave Medical, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK242926 XBody Go USA, XBody Pro USAXbody Hungary Kft. · 2025
Most influential descendants
Showing 4 of 4 · See all- K221200XBody Go USA, XBody Pro USAXbody Hungary Kft. · 2023 · cites it directly3descendants
- K250146SofWave SystemSofwave Medical, Ltd. · 2025 · 2 generations on1descendant
- K251746Pure ImpactSofwave Medical, Ltd. · 2025 · 3 generations on0descendants
- K242926XBody Go USA, XBody Pro USAXbody Hungary Kft. · 2025 · 2 generations on0descendants
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) | K190038 | Xbody Newave USA | Xbody Hungary Kft. | 2019 | — |
| +1 | K221200 | XBody Go USA, XBody Pro USA | Xbody Hungary Kft. | 2023 | — |
| +2 | K250146 | SofWave System | Sofwave Medical, Ltd. | 2025 | — |
| +3 | K251746 | Pure Impact | Sofwave Medical, Ltd. | 2025 | — |
| +2 | K242926 | XBody Go USA, XBody Pro USA | Xbody Hungary Kft. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K133225 | E-Fit EF-1280 Ems MachineSummary page 4…cation of Legally Marketed Predicate Device Name: E-Fit EF-1280 Manufacturer: FIT PRO, LLC K Number: K133225 D. Description of the Device The XBODY NEWAVE USA is a machine with electronic muscle stimulation based on EMS techn… | 2014 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221200 | XBody Go USA, XBody Pro USA | 2023 | 3 |
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 25 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, K221200 (Xbody Hungary Kft., 2023) has gone furthest, with 3 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. 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?
The XBODY NEWAVE 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 people (clients), not for rehabilitation purposes. The XBODY NEWAVE USA is intended to stimulate healthy muscles in order to improve or facilitate muscle performance The XBODY NEWAVE USA is not intended to be used in…
Read the full statement (224 words)
The XBODY NEWAVE 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 people (clients), not for rehabilitation purposes.
The XBODY NEWAVE USA is intended to stimulate healthy muscles in order to improve or facilitate muscle performance The XBODY NEWAVE 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 NEWAVE USA training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.
The XBODY NEWAVE 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 NEWAVE USA can impose on the stimulated muscles are able to improve or facilitate muscle performance. The XBODY NEWAVE USA may therefore be considered a technique of muscle training.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190038 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190038: Xbody Newave USA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190038
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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