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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 K014127
Device Name KARMA DISCOVERY, MODEL KP40
Applicant
Vestil Manufacturing Corp.
900 Growth Pkwy.
Angola,  IN  46703
Applicant Contact RICH MICHAEL
Correspondent
Vestil Manufacturing Corp.
900 Growth Pkwy.
Angola,  IN  46703
Correspondent Contact RICH MICHAEL
Regulation Number890.3860
Classification Product Code
ITI  
Date Received12/17/2001
Decision Date 03/15/2002
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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