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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 K252370
Device Name GEN 4 JOY Wheelchair
Applicant
Free Wheelchair Mission
15279 Alton Pkwy.
Suite 300
Irvine,  CA  92618
Applicant Contact Keith Herr
Correspondent
Free Wheelchair Mission
15279 Alton Pkwy.
Suite 300
Irvine,  CA  92618
Correspondent Contact Bonnie Gonzalez
Regulation Number890.3850
Classification Product Code
IOR  
Date Received07/30/2025
Decision Date 07/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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