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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode, cutaneous
510(k) Number K230533
Device Name Motive™ Electrode
Applicant
CyMedica Orthopedics, Inc.
2120 East 6th Street
Suite 8
Tempe,  AZ  85288
Applicant Contact Kereshmeh Shahriari
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number882.1320
Classification Product Code
GXY  
Date Received02/27/2023
Decision Date 03/22/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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