# K243165: Limfa Therapy System (Limfa Therapy)

- Pathway: 510(k) (Traditional)
- Applicant: Eywa Srl
- Decided: May 15, 2025 after 227 days
- Product code: NGX (Stimulator, Muscle, Powered, For Muscle Conditioning)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K940301 (1994). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151834: BEMER Classic Set, BEMER Pro-Set, Bemer Int AG (2017) Summary page 5.
- K210174: BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set, Bemer Int AG (2021) Summary page 6.

## Indications for use
The indications for the Limfa Therapy System are to temporarily increase blood circulation in healthy leg muscles and to stimulate healthy muscles in order to improve and facilitate muscle performance.

Source page: https://510kreport.com/device/K243165
Methodology: https://510kreport.com/methodology