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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Powered Inflatable Tube
510(k) Number K192607
Device Name LiteWalk
Applicant
Viasonix , Ltd.
10 Hamelacha St.
Ra'Anana,  IL 4366105
Applicant Contact Shlomi Deler
Correspondent
Viasonix , Ltd.
10 Hamelacha St.
Ra'Anana,  IL 4366105
Correspondent Contact Shlomi Deler
Regulation Number890.5650
Classification Product Code
IRP  
Date Received09/20/2019
Decision Date 12/19/2019
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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