FDA 510(k) Application Details - K211850

Device Classification Name	Massager, Powered Inflatable Tube   More FDA Info for this Device
510(K) Number	K211850
Device Name	Massager, Powered Inflatable Tube
Applicant	Xiamen Healthpal Electronic Co.,Ltd No.170 Siming Park Tongan District, Xiamen City, Fujian Province, China Xiamen 361100 CN Other 510(k) Applications for this Company
Contact	Henry Zhang 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	06/15/2021
Decision Date	03/03/2022
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