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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K261175
Device Name WHILL (WHILL Model C2)
Applicant
Whill, Inc.
2-1-11, Higashi-Shinagawa
Shinagawa,  JP 1400002
Applicant Contact Tsuyoshi Iriyama
Correspondent
Whill, Inc.
2-1-11, Higashi-Shinagawa
Shinagawa,  JP 1400002
Correspondent Contact Tsuyoshi Iriyama
Regulation Number890.3860
Classification Product Code
ITI  
Date Received04/10/2026
Decision Date 06/12/2026
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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