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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 K934232
Device Name COMMUTER (MANUAL/POWER WHEELCLHAIR)
Applicant
Fortress Lite-Style Wheelchairs, Inc.
3000 K St. NW
Suite 500
Washington,  DC  20007
Applicant Contact ILENE KNABLE GOTTS
Correspondent
Fortress Lite-Style Wheelchairs, Inc.
3000 K St. NW
Suite 500
Washington,  DC  20007
Correspondent Contact ILENE KNABLE GOTTS
Regulation Number890.3860
Classification Product Code
ITI  
Date Received08/19/1993
Decision Date 03/29/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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