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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 K233485
Device Name M-Wave
Applicant
Zynex Medical, Inc.
9655 Maroon Circle
Englewood,  CO  80112
Applicant Contact Thomas Sandgaard
Correspondent
Zynex Medical, Inc.
9655 Maroon Circle
Englewood,  CO  80112
Correspondent Contact Harrison Tanksley
Regulation Number890.5850
Classification Product Code
IPF  
Date Received10/27/2023
Decision Date 01/26/2024
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
Predetermined Change
Control Plan Authorized		 No
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