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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 K193599
Device Name BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair
Applicant
21st Century Scientific, Inc.
4931 N Manufacturing Way
Coeur D'Alene,  ID  83815
Applicant Contact RD Davidson
Correspondent
21st Century Scientific, Inc.
4931 N Manufacturing Way
Coeur D'Alene,  ID  83815
Correspondent Contact RD Davidson
Regulation Number890.3860
Classification Product Code
ITI  
Date Received12/23/2019
Decision Date 09/03/2020
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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