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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 K221200
Device Name XBody Go USA, XBody Pro USA
XBody Hungary Kft.
György Aladár u. 35-39
Budapest,  HU 1125
Applicant Contact Orsolya Balog
Medical Device Academy, Inc.
345 Lincoln Hill Rd
Shrewsbury,  VT  05738
Correspondent Contact Bhoomika Joyappa
Regulation Number890.5850
Classification Product Code
Date Received04/26/2022
Decision Date 01/31/2023
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