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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 K950904
Device Name ORTHOFAB WHEELCHAIR ASTRA (FOLDING MANUAL WHEELCHAIR)
Applicant
Orthofab, Inc.
2160 De Celles
Quebec City (Quebec),  CA G2C 1X8
Applicant Contact CLAUDE ARCAND
Correspondent
Orthofab, Inc.
2160 De Celles
Quebec City (Quebec),  CA G2C 1X8
Correspondent Contact CLAUDE ARCAND
Regulation Number890.3850
Classification Product Code
IOR  
Date Received02/28/1995
Decision Date 04/05/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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