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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 K200715
Device Name RoughRider Aurora Manual Wheelchair
Applicant
Roughrider America, LLC
2233 California St.
Berkley,  CA  94703
Applicant Contact Marc Krizack
Correspondent
Roughrider America, LLC
2233 California St.
Berkley,  CA  94703
Correspondent Contact Marc Krizack
Regulation Number890.3850
Classification Product Code
IOR  
Date Received03/18/2020
Decision Date 06/24/2022
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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