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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 K954135
Device Name POWERCHAIR
Applicant
Wheelcare Scooters, Inc.
3883 - E Via Prescador
Camarillo,  CA  93012
Applicant Contact HAROLD GUTTERMAN
Correspondent
Wheelcare Scooters, Inc.
3883 - E Via Prescador
Camarillo,  CA  93012
Correspondent Contact HAROLD GUTTERMAN
Regulation Number890.3860
Classification Product Code
ITI  
Date Received09/01/1995
Decision Date 04/10/1996
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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