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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 K905293
Device Name SYSTEM 90 AND 95
Applicant
Folio Products, Inc.
1341 Sherman Dr.
Unit A
Longmont,  CO  80501
Applicant Contact W. F KIDWELL
Correspondent
Folio Products, Inc.
1341 Sherman Dr.
Unit A
Longmont,  CO  80501
Correspondent Contact W. F KIDWELL
Regulation Number890.3860
Classification Product Code
ITI  
Date Received11/23/1990
Decision Date 12/06/1990
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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