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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 K030250
Device Name IGLIDE MANUAL ASSIST WHEELCHAIR
Applicant
Independence Technology, LLC
40 Technology Dr.
P.O. Box 4917
Warren,  NJ  07059 -4917
Applicant Contact JAMES P O'DONNELL
Correspondent
Independence Technology, LLC
40 Technology Dr.
P.O. Box 4917
Warren,  NJ  07059 -4917
Correspondent Contact JAMES P O'DONNELL
Regulation Number890.3860
Classification Product Code
ITI  
Date Received01/24/2003
Decision Date 03/04/2003
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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