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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 K190038
Device Name Xbody Newave USA
Applicant
Xbody Hungary Kft.
Gyorgy Aladar U. 35-39
Budapest,  HU 1125
Applicant Contact Peter Tar
Correspondent
Biomedical Regulatory Consulting
9203 Hwy 6 S., Suite 124
Houston,  TX  77083
Correspondent Contact R. William Soller
Regulation Number890.5850
Classification Product Code
NGX  
Date Received01/08/2019
Decision Date 04/05/2019
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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