Xbody Newave USA

Stimulator, Muscle, Powered, For Muscle Conditioning

XBody Hungary Kft.

The following data is part of a premarket notification filed by Xbody Hungary Kft. with the FDA for Xbody Newave Usa.

Pre-market Notification Details

Device IDK190038
510k NumberK190038
Device Name:Xbody Newave USA
ClassificationStimulator, Muscle, Powered, For Muscle Conditioning
Applicant XBody Hungary Kft. Gyorgy Aladar U. 35-39 Budapest,  HU 1125
ContactPeter Tar
CorrespondentR. William Soller
Biomedical Regulatory Consulting 9203 Hwy 6 South, Suite 124 Houston,  TX  77083
Product CodeNGX  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-01-08
Decision Date2019-04-05


Device IdentifiersubmissionNumberSupplement
05999860571001 K190038 000

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