FDA 510(k) Application Details - K213788

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K213788
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	Dongguan Bohuikang Technology Co.,Ltd 5th Floor,No 5, Second Street,Huaide Shui Xiang New Strict, Humen Town DongGuan 523165 CN Other 510(k) Applications for this Company
Contact	Rihua Meng 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	12/06/2021
Decision Date	05/06/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review