Class Class II
Limfa Therapy System (Limfa Therapy) (K243165)
Description
Limfa Therapy System (Limfa Therapy) by Eywa Srl, an FDA 510(k) cleared physical medicine device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243165
Clearance Date2025-05-15
Clearance TypeTraditional
Product CodeNGX
Regulation Number890.5850
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243165
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. Limfa Therapy System (Limfa Therapy) (K243165) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210174 | BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set | Bemer Int AG | 2021 |
| K151834 | BEMER Classic Set, BEMER Pro-Set | Bemer Int AG | 2017 |
Trace the full predicate network for K243165
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.