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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
Original Applicant
ZYNEX MEDICAL, INC.
9990 park meadows dr.
lone tree,  CO  80124
Original Contact jim arnold
Regulation Number876.5320
Classification Product Code
KPI  
Date Received06/21/2012
Decision Date 08/24/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
statement statement
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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