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FDA 510(k) Application Details - K220227
Device Classification Name
Vehicle, Motorized 3-Wheeled
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510(K) Number
K220227
Device Name
Vehicle, Motorized 3-Wheeled
Applicant
Heartway Medical Products Co., Ltd.
No.18, Jingke Central 1st Rd., Nantun Dist
Taichung City 40852 TW
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Contact
Ke-Min Jen
Other 510(k) Applications for this Contact
Regulation Number
890.3800
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Classification Product Code
INI
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More FDA Info for this Product Code
Date Received
01/27/2022
Decision Date
10/12/2022
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
N
Expedited Review
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