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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 K143101
Device Name Helio A7 Manual Wheelchair, Move Manual Wheelchair
Applicant
Motion Composites
519 J-Oswald-Forest
Suite 101
Saint-Roch-De-L' Achigan,  CA J0K 3H0
Applicant Contact Vincent Leuyer
Correspondent
Spectre Solutions, Inc.
5905 Fawn Lane
Cleveland,  OH  44141
Correspondent Contact Edward A. Kroll
Regulation Number890.3850
Classification Product Code
IOR  
Date Received10/29/2014
Decision Date 05/01/2015
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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