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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 K010917
Device Name POWER TILT AND RECLINE SYSTEM
Applicant
SUNRISE MEDICAL, INC.
7477 EAST DRY CREEK PKWY.
LONGMONT,  CO  80503
Applicant Contact JOHN GERHOLD
Correspondent
SUNRISE MEDICAL, INC.
7477 EAST DRY CREEK PKWY.
LONGMONT,  CO  80503
Correspondent Contact JOHN GERHOLD
Regulation Number890.3860
Classification Product Code
ITI  
Date Received03/27/2001
Decision Date 05/15/2001
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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