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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 K221438
Device Name WHILL Model F
Applicant
Whill, Inc.
2-1-11 Higashi-Shinagawa; Harbor Premium Bldg. 2f
Shinagawa-Ku,  JP 140-0002
Applicant Contact Tsuyoshi Iriyama
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number890.3860
Classification Product Code
ITI  
Date Received05/17/2022
Decision Date 06/07/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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