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510(k) Data Aggregation
K Number
K243165Device Name
Limfa Therapy System (Limfa Therapy)
Manufacturer
EYWA srl
Date Cleared
2025-05-15
(227 days)
Product Code
NGX
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
EYWA srl
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
Device Description
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.
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