Class Class II
Pure Impact (K251746)
Description
Pure Impact by Sofwave Medical, Ltd., an FDA 510(k) cleared physical medicine device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251746
Clearance Date2025-07-02
Clearance TypeSpecial
Product CodeNGX
Regulation Number890.5850
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251746
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. Pure Impact (K251746) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250146 | SofWave System | Sofwave Medical, Ltd. | 2025 |
Trace the full predicate network for K251746
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.