XBODY HUNGARY Kft.

Address:Torok Ignac u. 66,Gyor,HU

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Stimulator, Muscle, Powered, For Muscle Conditioning (NGX) (1)

Premarket Exempt

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XBody - 05999860571001 Catalog Number :

Device Description : The XBody Newave USA is a machine with electronic muscle stimulation based on EM The XBody Newave USA is a machine with electronic muscle stimulation based on EMS technology. The device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes.

Device Class : 2

Duns Number: 366728377

Premarket Exempt : No

Product Code : NGX

Prescription Use : No

Device Count : 1

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