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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 K251594
Device Name truFlex
Applicant
Syrma Johari Medtech Limited
G-582-584, Epip, Boranada
Jodhpur,  IN 342012
Applicant Contact Sabyasachi Nath
Correspondent
Syrma Johari Medtech Limited
G-582-584, Epip, Boranada
Jodhpur,  IN 342012
Correspondent Contact Sabyasachi Nath
Regulation Number890.5850
Classification Product Code
NGX  
Date Received05/27/2025
Decision Date 08/28/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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