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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Non-Implantable, For Incontinence
510(k) Number K121820
Device Name INWAVE
Applicant
Zynex Medical, Inc.
9990 Park Meadows Dr.
Lone Tree,  CO  80124
Applicant Contact JIM ARNOLD
Correspondent
Zynex Medical, Inc.
9990 Park Meadows Dr.
Lone Tree,  CO  80124
Correspondent Contact JIM ARNOLD
Regulation Number876.5320
Classification Product Code
KPI  
Date Received06/21/2012
Decision Date 08/24/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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