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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K111095
Device Name BREEZE ELECTRIC TRANSPORT CHAIR MODEL 1025
Applicant
Electro Kinetic Technologies, LLC
W194n11301 Mccormick Dr.
Gemantown,  WI  53022
Applicant Contact RAYMOND ERBE
Correspondent
Electro Kinetic Technologies, LLC
W194n11301 Mccormick Dr.
Gemantown,  WI  53022
Correspondent Contact RAYMOND ERBE
Regulation Number890.3860
Classification Product Code
ITI  
Date Received04/20/2011
Decision Date 08/03/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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