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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 K983520
Device Name BREATH CONTROL (BREATH ACTUATOR), SENSITOUCH BREATH CONTROL, HEAD ARRAY (SWITCH HEAD CONTROL), TRI-SWITCH HEAD ARRAY, HD
Applicant
Sunrise Medical, Inc.
7477a E. Dry Creek Pkwy.
Longmont,  CO  80503
Applicant Contact REBECCA ANDERSEN
Correspondent
Sunrise Medical, Inc.
7477a E. Dry Creek Pkwy.
Longmont,  CO  80503
Correspondent Contact REBECCA ANDERSEN
Regulation Number890.3860
Classification Product Code
ITI  
Date Received10/08/1998
Decision Date 11/06/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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