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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 K955548
Device Name CHIPS POWERED WHEELCHAIR
Applicant
INTERNATIONAL HEALTHCARE SOLUTIONS, INC.
368 W. VETERANS HIGHWAY
COMMACK,  NY  11725
Applicant Contact FRED DI VITO
Correspondent
INTERNATIONAL HEALTHCARE SOLUTIONS, INC.
368 W. VETERANS HIGHWAY
COMMACK,  NY  11725
Correspondent Contact FRED DI VITO
Regulation Number890.3860
Classification Product Code
ITI  
Date Received12/05/1995
Decision Date 09/20/1996
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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