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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 K984367
Device Name ACTIVX
Applicant
Adorno Rogers Technology
101 W. 6th St., Suite 409
Austin,  TX  78701
Applicant Contact PAUL GIBB
Correspondent
Adorno Rogers Technology
101 W. 6th St., Suite 409
Austin,  TX  78701
Correspondent Contact PAUL GIBB
Regulation Number890.3850
Classification Product Code
IOR  
Date Received12/07/1998
Decision Date 01/28/1999
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
Predetermined Change
Control Plan Authorized		 No
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