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FDA 510(k) Application Details - K242760
Device Classification Name
Vehicle, Motorized 3-Wheeled
More FDA Info for this Device
510(K) Number
K242760
Device Name
Vehicle, Motorized 3-Wheeled
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
890.3800
More FDA Info for this Regulation Number
Classification Product Code
INI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/12/2024
Decision Date
01/06/2025
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
N
Expedited Review
FDA Source Information for K242760
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