Limfa Therapy System (Limfa Therapy)

GUDID 08059916140005

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

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 08059916140005
• NIH Device Record Key: 0a1f78dc-b155-41ab-ab5c-5a6f07226290
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Limfa Therapy System (Limfa Therapy)
• Version Model Number: LMF000THR
• Company DUNS: 431064194
• Company Name: EYWA SRL
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	08059916140005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243165

FDA Product Code

• NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-06
• Device Publish Date: 2026-01-29