FDA 510(k) Application Details - K243791

Device Classification Name	Massager, Powered Inflatable Tube   More FDA Info for this Device
510(K) Number	K243791
Device Name	Massager, Powered Inflatable Tube
Applicant	Xiamen WeiYou Intelligent Technology Co.,Ltd. Unit 101-401,No.6 Xianghong Road,Xiang'an District Xiamen 361021 CN Other 510(k) Applications for this Company
Contact	Guo Kelly 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	12/10/2024
Decision Date	01/13/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review