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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 K251886
Device Name EmpowerRide NAVIGATOR
Applicant
Empower Ride, LLC
18874 Patrick Ave. Elkhorn
Elkhorn,  NE  68022
Applicant Contact Peter Anaradian
Correspondent
Empower Ride, LLC
18874 Patrick Ave. Elkhorn
Elkhorn,  NE  68022
Correspondent Contact Peter Anaradian
Regulation Number890.3850
Classification Product Code
IOR  
Subsequent Product Code
LBE  
Date Received06/20/2025
Decision Date 01/12/2026
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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