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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered, For Muscle Conditioning
510(k) Number K243165
Device Name Limfa Therapy System (Limfa Therapy)
Applicant
Eywa Srl
Via Pietrarubbia N. 25/E
N. 25/E
Rimini,  IT 47922
Applicant Contact Tommaso Faiella
Correspondent
Eywa Srl America
1224 Navellier St.
El Cerrito,  CA  94530
Correspondent Contact Thomas Lawson
Regulation Number890.5850
Classification Product Code
NGX  
Date Received09/30/2024
Decision Date 05/15/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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