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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
XBody Hungary Kft.
Gyorgy Aladar u. 35-39
Budapest,  HU 1125
Applicant Contact Peter Tar
Biomedical Regulatory Consulting
9203 Hwy 6 South, Suite 124
Houston,  TX  77083
Correspondent Contact R. William Soller
Regulation Number890.5850
Classification Product Code
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