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FDA 510(k) Application Details - K212935
Device Classification Name
Massager, Powered Inflatable Tube
More FDA Info for this Device
510(K) Number
K212935
Device Name
Massager, Powered Inflatable Tube
Applicant
Xiamen Simo Electronic Co., Ltd
Floor 3rd-5th, No. 173 Siming Park,
Tong'an Industrial Zone, Tong'an District
Xia Men 361100 CN
Other 510(k) Applications for this Company
Contact
Wang Qinsheng
Other 510(k) Applications for this Contact
Regulation Number
890.5650
More FDA Info for this Regulation Number
Classification Product Code
IRP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/15/2021
Decision Date
02/19/2022
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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