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FDA 510(k)

Limfa Therapy System (Limfa Therapy)

K-Number: K243165 · 2025-05-15

ApplicantEywa Srl
Decision Date2025-05-15
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Limfa Therapy System (Limfa Therapy) is the device name listed in this FDA 510(k) record. The listed applicant is Eywa Srl. It received FDA 510(k) clearance on 2025-05-15 under 510(k) number K243165. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Limfa Therapy System (Limfa Therapy)?

Limfa Therapy System (Limfa Therapy) is a medical device that received FDA 510(k) clearance on 2025-05-15. The listed applicant is Eywa Srl. The 510(k) number is K243165.

When did Limfa Therapy System (Limfa Therapy) receive FDA 510(k) clearance?

Limfa Therapy System (Limfa Therapy) received FDA 510(k) clearance on 2025-05-15, under 510(k) number K243165.

Who is the listed applicant for Limfa Therapy System (Limfa Therapy)?

The FDA 510(k) record lists Eywa Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Limfa Therapy System (Limfa Therapy)?

The FDA product code for Limfa Therapy System (Limfa Therapy) is NGX.

Related Devices (Code: NGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253790High Intensity Focused Electromagnetic Stimulation Device (FE60)Beijing Winkonlaser Technology LimitedK253926DiacoreShenB Co., Ltd.K253636Zionic Pro Max (EMS)Termosalud S.L.K253408CoolToneZimmer Medizinsysteme GmbHK252154Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)Guangzhou Longest Medical Technology Co., Ltd.K253478Motive™ Muscle Stimulator for Lower Back (OT01-1003)Motive Health, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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