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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 K152827
Device Name Weely Manual Wheelchair
Applicant
Rupiani
74 Ave. Du 8 Mai 1945
Vaudex En Velin,  FR 69120
Applicant Contact Jean-Marie Mangenot
Correspondent
Spectre Solutions, Inc.
5905 Fawn Lane
Cleveland,  OH  44141
Correspondent Contact Edward A Kroll
Regulation Number890.3850
Classification Product Code
IOR  
Date Received09/29/2015
Decision Date 02/19/2016
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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