FDA 510(k) Application Details - K250759

Device Classification Name	More FDA Info for this Device
510(K) Number	K250759
Device Name	3 in 1 TENS UNIT
Applicant	Changsha Anxiang Medical Technology Co., LTD Room 2404, Kairui Building,No. 245 Laodong West Road, Tianxin District Changsha 410007 CN Other 510(k) Applications for this Company
Contact	William Fu Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/13/2025
Decision Date	06/13/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review