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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 K241685
Device Name SofWave System
Applicant
Sofwave Medical Ltd.
1 Ha-Otsma St.
Yokneam Ilit,  IL 2069200
Applicant Contact Ruthie Amir
Correspondent
Sofwave Medical Ltd.
1 Ha-Otsma St.
Yokneam Ilit,  IL 2069200
Correspondent Contact Ruthie Amir
Regulation Number890.5850
Classification Product Code
NGX  
Subsequent Product Code
OHV  
Date Received06/11/2024
Decision Date 08/07/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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