FDA 510(k) Application Details - K243206

Device Classification Name	Massager, Powered Inflatable Tube   More FDA Info for this Device
510(K) Number	K243206
Device Name	Massager, Powered Inflatable Tube
Applicant	Sichuan Qianli-beoka Medical Technology Inc. Longtan Industrial Park 2nd Sec, East 3rd Ring Road Chenghua District Chengdu 610052 CN Other 510(k) Applications for this Company
Contact	Qiuju 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	10/01/2024
Decision Date	02/19/2025
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