FDA 510(k) Application Details - K241446

Device Classification Name	Massager, Powered Inflatable Tube   More FDA Info for this Device
510(K) Number	K241446
Device Name	Massager, Powered Inflatable Tube
Applicant	Sichuan QianIi-beoka Medical TechnoIogy lnc. Longtan lndustrial Park 2nd Sec,east 3rd ring road, Chenghua district Chengdu CN Other 510(k) Applications for this Company
Contact	Zeng Wei 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	05/22/2024
Decision Date	10/08/2024
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