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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 K201257
Device Name MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)
Applicant
Arrive Systems Inc
113 Brakdale
New Ark,  DE  19711
Applicant Contact Aseem Gupta
Correspondent
IUVO Consulting, LLC
PO Box 56436
Virginia Beach,  VA  23456
Correspondent Contact Rhonda Alexander
Regulation Number890.5850
Classification Product Code
NGX  
Subsequent Product Code
GZJ  
Date Received05/11/2020
Decision Date 04/06/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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