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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K162328
Device Name Winner Transfer Wheelchair
Applicant
Winner SG Pte, Ltd.
14 Little Rd. #07-01 Tropical Industrial Bldg.
Singapore,  SG 536987
Applicant Contact Michael Pang
Correspondent
Eminence Clinical Research, Inc.
1880 Office Club Pointe, Suite 1360
Colorado Springs,  CO  80920
Correspondent Contact Diane Horwitz
Regulation Number890.3850
Classification Product Code
IOR  
Date Received08/19/2016
Decision Date 05/11/2017
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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