FDA 510(k) Application Details - K221992

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K221992
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	Beijing Choice Electronic Technology Co., Ltd. No.9 Shuangyuan road, Badachu Hi-tech Zone Shijingshan District Beijing 100041 CN Other 510(k) Applications for this Company
Contact	Haiying Zhao 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	07/06/2022
Decision Date	10/21/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review