FDA 510(k) Application Details - K242567

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K242567
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	Changsha Anxiang Medical Technology Co., Ltd. 9th Floor, R&D Center and Supporting Projects 101, No.18 Shanshan Middle Road, Dongtang Street, Yuhua District Changsha 410000 CN Other 510(k) Applications for this Company
Contact	William Fu Other 510(k) Applications for this Contact
Regulation Number	882.5890   More FDA Info for this Regulation Number
Classification Product Code	NUH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/29/2024
Decision Date	11/04/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review