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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 K163067
Device Name CyMedica e-vive™ System; CY-1000
Applicant
Cymedica Orthopedics, Inc.
19120 N. Pima Rd.
Suite 135
Scottsdale,  AZ  85255
Applicant Contact Kereshmeh Shahriari
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Codes
GZJ   KQX  
Date Received11/02/2016
Decision Date 12/01/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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