FDA 510(k) Application Details - K240358

Device Classification Name	Massager, Therapeutic, Electric   More FDA Info for this Device
510(K) Number	K240358
Device Name	Massager, Therapeutic, Electric
Applicant	Shenzhen Dongdixin Technology Co., Ltd. Floor 1-2, No.3 Building, Fanshen Xusheng Industrial Estate Xilixiaobaimang Nanshan District Shenzhen 518108 CN Other 510(k) Applications for this Company
Contact	Yuan Siping Other 510(k) Applications for this Contact
Regulation Number	890.5660   More FDA Info for this Regulation Number
Classification Product Code	ISA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/06/2024
Decision Date	06/05/2024
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