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510(k) K190038

Xbody Newave USA by Xbody Hungary Kft. — Product Code NGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2019
Date Received
January 8, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered, For Muscle Conditioning
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type

A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatigue resistance. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this device is not intended for use in patients with medical conditions and is intended only for muscle conditioning purposes.

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