Class Class II
SofWave System (K250146)
Description
SofWave System by Sofwave Medical, Ltd., an FDA 510(k) cleared physical medicine device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250146
Clearance Date2025-04-18
Clearance TypeTraditional
Product CodeNGX
Regulation Number890.5850
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250146
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. SofWave System (K250146) cites 4 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241685 | SofWave System | Sofwave Medical, Ltd. | 2024 |
| K233104 | SofWave System | Sofwave Medical, Ltd. | 2023 |
| K221200 | XBody Go USA, XBody Pro USA | Xbody Hungary Kft. | 2023 |
| K143551 | Compex Wireless USA | Djo, LLC | 2015 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K251746 | Pure Impact | Sofwave Medical, Ltd. | 2025 |
Trace the full predicate network for K250146
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.