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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 K213383
Device Name WHILL Model C2
Applicant
Whill, Inc.
2-1-11 Higashi-Shinagawa; Harbor Premium Building 2F
Shinagawa-ku,  JP 140-0002
Applicant Contact Tsuyoshi Iriyama
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number890.3860
Classification Product Code
ITI  
Date Received10/13/2021
Decision Date 11/09/2021
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
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