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FDA 510(k) Application Details - K221438
Device Classification Name
Wheelchair, Powered
More FDA Info for this Device
510(K) Number
K221438
Device Name
Wheelchair, Powered
Applicant
Whill, Inc.
2-1-11 Higashi-Shinagawa; Harbor Premium Building 2F
Shinagawa-ku 140-0002 JP
Other 510(k) Applications for this Company
Contact
Tsuyoshi Iriyama
Other 510(k) Applications for this Contact
Regulation Number
890.3860
More FDA Info for this Regulation Number
Classification Product Code
ITI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/17/2022
Decision Date
06/07/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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