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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 K243111
Device Name Bowhead ERA Wheelchairs
Applicant
Bowhead Design Corp.
6919 32 Ave. NW
Calgary,  CA T3B 0K6
Applicant Contact Tatiana Place
Correspondent
QUARAS, LLC
2101 Camino Rey
Fullerton,  CA  92833
Correspondent Contact Roshana Ahmed
Regulation Number890.3850
Classification Product Code
IOR  
Date Received09/30/2024
Decision Date 01/10/2025
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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