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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K913901
Device Name FREEDOM WHEELS AZ 100
Applicant
Arizona Freedom Wheels, Inc.
P.O. Box 42585
Phoenix,  AZ  85080
Applicant Contact JOHN WRZESINSKI
Correspondent
Arizona Freedom Wheels, Inc.
P.O. Box 42585
Phoenix,  AZ  85080
Correspondent Contact JOHN WRZESINSKI
Regulation Number890.3860
Classification Product Code
ITI  
Date Received08/30/1991
Decision Date 10/07/1991
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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