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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 K061010
Device Name FUTURE MOBILITY HEALTHCARE INC. ORION II WHEELCHAIR AND STELLATO MECHANICAL WHEELCHAIR
Applicant
Future Mobility Healthcare, Inc.
2775 Slough St.
Mississauga, On,  CA L4T 1G2
Applicant Contact WILLIAM SALTER
Correspondent
Future Mobility Healthcare, Inc.
2775 Slough St.
Mississauga, On,  CA L4T 1G2
Correspondent Contact WILLIAM SALTER
Regulation Number890.3850
Classification Product Code
IOR  
Date Received04/12/2006
Decision Date 05/23/2006
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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