FDA 510(k) Application Details - K223464

Device Classification Name	Massager, Powered Inflatable Tube   More FDA Info for this Device
510(K) Number	K223464
Device Name	Massager, Powered Inflatable Tube
Applicant	Zhangzhou Easepal Innovation Co Ltd. No.36 Longkun Road, Hongjian Village, Jiaomei Town, Zhangzhou, Taiwanese Investment Zone Zhangzhou 363000 CN Other 510(k) Applications for this Company
Contact	Xu Zibing 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	11/17/2022
Decision Date	03/14/2023
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