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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 K851261
Device Name ALEXIS
Applicant
Intex Research & Development Center
921 Alma St.
Palo Alto,  CA  94301
Applicant Contact PETER AXELSON
Correspondent
Intex Research & Development Center
921 Alma St.
Palo Alto,  CA  94301
Correspondent Contact PETER AXELSON
Regulation Number890.3860
Classification Product Code
ITI  
Date Received03/28/1985
Decision Date 07/01/1985
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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