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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Standup
510(k) Number K150548
Device Name Tek RMD (Tek Robotic Mobilization Device)
Applicant
Matia Robotics Mekatroik Sis. Ar-Ge Muh. Yaz.San VE Tic.A.S
Dudullu Organize Sanayi Bolgesi 3. Cad.
And Sanyi Sitesi No:16/7
Istanbul,  TR 34775
Applicant Contact Necati Hacikadiroglu
Correspondent
Third Party Review Group, LLC
45 Rockefeller Plaza, Suite 2000
New York,  NY  10111
Correspondent Contact DAVE YUNGVIRT
Regulation Number890.3900
Classification Product Code
IPL  
Date Received03/03/2015
Decision Date 06/11/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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