FDA.reportPublic FDA data

EYWA

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30241821693024182169EYWA S.R.L.1N2026-01-01Via Pietrarubbia 25/E Rimini IT 47922

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3446941549068808K243165Limfa Therapy System (Limfa Therapy)NGX2025-05-15

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NGX12025-05-15

NDC#

PMN#

Applications#

GUDID#

Limfa Therapy System (Limfa Therapy) - The Limfa Therapy System is a medical device, intended for stimulation with extremely low frequencies (ELF), pulsed, and low frequency (ELF 3-300 Hz) magnetic fields, which generates pulsed, bipolar and variable electromagnetic fields, at very low and variable intensity and frequency using complex waveforms (sinusoidal, triangular and rectangular), thus obtaining multiple signals within a frequency spectrum composed of base waves from 2 to 80 Hz plus the harmonics that are produced by the hardware component. The manufacturer presets base wave frequencies and the harmonics are generated by the DM hardware. The therapy is based on the generation of a pulsed magnetic field with a very low and variable frequency and variable intensity.

EYWA SRL

2026-01-29