FDA 510(k) Application Details - K192358

Device Classification Name	Massager, Powered Inflatable Tube   More FDA Info for this Device
510(K) Number	K192358
Device Name	Massager, Powered Inflatable Tube
Applicant	Xiamen Senyang Co., Ltd. 4-5 Floor, Xingbei Industry, No 95-99, West 2 Road Jiu Tianhu Xinglin Xiamen 361000 CN Other 510(k) Applications for this Company
Contact	Nina Cai 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	08/29/2019
Decision Date	04/23/2020
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