FDA 510(k) Application Details - K240373

Device Classification Name	Massager, Powered Inflatable Tube   More FDA Info for this Device
510(K) Number	K240373
Device Name	Massager, Powered Inflatable Tube
Applicant	Zhangzhou Easepal Medical Science And Technology Co., Ltd. West of the 4th Floor, No. 7 Building, Easepal Factory, No. 228 Jiaosong Road, Jiaomei Town, Zhangzhou CN Other 510(k) Applications for this Company
Contact	Yuehua Huang 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	02/07/2024
Decision Date	09/17/2024
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