Class Class II
XBody Go USA, XBody Pro USA (K221200)
Description
XBody Go USA, XBody Pro USA by Xbody Hungary Kft., an FDA 510(k) cleared physical medicine device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221200
Clearance Date2023-01-31
Clearance TypeTraditional
Product CodeNGX
Regulation Number890.5850
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221200
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. XBody Go USA, XBody Pro USA (K221200) cites 2 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K190038 | Xbody Newave USA | Xbody Hungary Kft. | 2019 |
| K181955 | WiEMSpro | Medical Cables S.L. | 2019 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242926 | XBody Go USA, XBody Pro USA | Xbody Hungary Kft. | 2025 |
| K250146 | SofWave System | Sofwave Medical, Ltd. | 2025 |
Trace the full predicate network for K221200
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.