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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 K190699
Device Name Rowheels Revolution 1.0
Applicant
Rowheels, Inc.
8001 Ter. Ave., Suite 204
Middleton,  WI  53562
Applicant Contact Matthew Doeppers
Correspondent
FDA Compliance Group
33 Golden Eagle Ln.
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number890.3850
Classification Product Code
IOR  
Date Received03/18/2019
Decision Date 05/09/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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