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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 K230385
Device Name Ballancer Platinum (1222)
Applicant
Mego Afek
Kibbuts Afek
Kibbuts Afek,  IL 3004200
Applicant Contact Yunger Reuven
Correspondent
Ilan Sharon MD Consultant
P.O. Box 4414(A109)
Caesarea,  IL 3088900
Correspondent Contact Ilan Sharon
Regulation Number890.5650
Classification Product Code
IRP  
Date Received02/14/2023
Decision Date 04/04/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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