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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 K190550
Device Name IKON 40 Manual Wheelchair
Applicant
Broda Seating (Broda Lp)
560 Bingemans Centre Dr.
Kitchener,  CA N2B3X9
Applicant Contact Jeremy Ballard
Correspondent
Broda Seating (Broda Lp)
560 Bingemans Centre Dr.
Kitchener,  CA N2B3X9
Correspondent Contact Jeremy Ballard
Regulation Number890.3850
Classification Product Code
IOR  
Date Received03/05/2019
Decision Date 07/01/2019
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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