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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 K022704
Device Name TAILWIND
Applicant
Deltaglide
3 Industrial Cir.
Hamden,  CT  06517
Applicant Contact JERE PERCHY
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Correspondent Contact HEINZ JOERG STENEBERG
Regulation Number890.3860
Classification Product Code
ITI  
Date Received08/14/2002
Decision Date 08/27/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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