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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 K222386
Device Name Visionbody
VB Technologies AG
Baarerstrasse 12
Zug,  CH 6300
Applicant Contact Jorge Millan
VB Technologies AG
Baarerstrasse 12
Zug,  CH 6300
Correspondent Contact Jorge Millan
Regulation Number890.5850
Classification Product Code
Date Received08/08/2022
Decision Date 02/24/2023
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