FDA 510(k) Application Details - K233040

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K233040
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	Shenzhen IMDK Medical Technology Co., Ltd. 904, 9F, Guangming Tianan Cloud Park Building, 255 Zhenmei Road, Zhenmei Community,Xinhu Street Shenzhen 518107 CN Other 510(k) Applications for this Company
Contact	Yuan Xia 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	09/25/2023
Decision Date	02/12/2024
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