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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 K150413
Device Name QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator
Applicant
Cymedica Orthopedics, Inc.
19120 N. Pima Rd.
Suite 135
Scottsdale,  AZ  85255
Applicant Contact Kereshmeh Shahriari
Correspondent
Third Party Review Group, LLC
45 Rockefeller Plaza, Suite 2000
New York,  NY  10111
Correspondent Contact DAVE YUNGVIRT
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Code
GZJ  
Date Received02/18/2015
Decision Date 04/02/2015
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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