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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
510(k) Number K213197
Device Name MyOnyx System
Applicant
Thought Technology , Ltd.
5250 Ferrier, Suite 812
Montreal,  CA H4P 1L3
Applicant Contact Suresh Sugirtharaja
Correspondent
Thought Technology , Ltd.
5250 Ferrier, Suite 812
Montreal,  CA H4P 1L3
Correspondent Contact Suresh Sugirtharaja
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Code
GZJ  
Date Received09/29/2021
Decision Date 06/17/2022
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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