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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 K111279
Device Name NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM
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 Number890.5850
Classification Product Code
IPF  
Subsequent Product Codes
GZJ   LIH  
Date Received05/05/2011
Decision Date 09/20/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
statement statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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