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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 K972797
Device Name TOOL-LESS WHEEL CHAIR
Applicant
SUNRISE MEDICAL, INC.
7477A EAST DRY CREEK PKWY.
LONGMONT,  CO  80503
Applicant Contact REBECCA ANDERSEN
Correspondent
SUNRISE MEDICAL, INC.
7477A EAST DRY CREEK PKWY.
LONGMONT,  CO  80503
Correspondent Contact REBECCA ANDERSEN
Regulation Number890.3850
Classification Product Code
IOR  
Date Received07/28/1997
Decision Date 08/12/1997
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
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