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FDA 510(k) Application Details - K241154
Device Classification Name
Wheelchair, Powered
More FDA Info for this Device
510(K) Number
K241154
Device Name
Wheelchair, Powered
Applicant
IF Health (Xiamen) Intelligent Technology Co.,Ltd
Zone A, 4th Floor, No.3 Building, No.66, xiangyue Rd,
Torch High-tech Zone(XiangÆan) Industrial Zone
Xiamen CN
Other 510(k) Applications for this Company
Contact
Xiang Gao
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
04/26/2024
Decision Date
06/28/2024
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 K241154
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