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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 K251746
Device Name Pure Impact
Applicant
Sofwave Medical, Ltd.
1 Ha-Otsma St.
Yokneam Iiit,  IL 2069200
Applicant Contact Ruthie Amir
Correspondent
Hogan Lovells US LLP
1735 Market St., Suite 2300
Hiladelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number890.5850
Classification Product Code
NGX  
Date Received06/06/2025
Decision Date 07/02/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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