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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 K242926
Device Name XBody Go USA, XBody Pro USA
Applicant
Xbody Hungary Kft.
György Aladár U. 35-39.
Budapest,  HU 1125
Applicant Contact Orsolya Balog
Correspondent
Medical Device Academy, Inc.
345
Lincoln Hill Rd.
Shrewsbury,  VT  05738
Correspondent Contact Bhoomika Joyappa
Regulation Number890.5850
Classification Product Code
NGX  
Date Received09/24/2024
Decision Date 05/30/2025
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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