FDA 510(k) Application Details - K213000

Device Classification Name	Massager, Powered Inflatable Tube   More FDA Info for this Device
510(K) Number	K213000
Device Name	Massager, Powered Inflatable Tube
Applicant	Wenzhou Lingfeng Electronic Technology Co., Ltd No.9,Jintang Road,Jielu Industry District,Bishan Town Ruian 325200 CN Other 510(k) Applications for this Company
Contact	Xiaoqun Ye 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	09/20/2021
Decision Date	11/15/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review