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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 K171092
Device Name XiniWave II Model ECS322P
Applicant
International Trade Group, Inc.
4663 Katie Lane
Oxford,  OH  45056
Applicant Contact Brent C. Reider
Correspondent
International Trade Group, Inc.
4663 Katie Lane
Oxford,  OH  45056
Correspondent Contact Brent C. Reider
Regulation Number890.5850
Classification Product Code
NGX  
Subsequent Product Code
NUH  
Date Received04/12/2017
Decision Date 07/10/2017
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
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