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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 K103073
Device Name SUPER CHAIR FOR KIDS BY ORION
Applicant
Future Mobility Healthcare, Inc.
3223 Orlando Dr.
Mississauga, Ontario,  CA L4V 1C5
Applicant Contact ABDULSAMAD PANCHBHAYA
Correspondent
Future Mobility Healthcare, Inc.
3223 Orlando Dr.
Mississauga, Ontario,  CA L4V 1C5
Correspondent Contact ABDULSAMAD PANCHBHAYA
Regulation Number890.3850
Classification Product Code
IOR  
Date Received10/18/2010
Decision Date 01/03/2011
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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