FDA 510(k) Application Details - K202861

Device Classification Name	Stimulator, Electro-Acupuncture   More FDA Info for this Device
510(K) Number	K202861
Device Name	Stimulator, Electro-Acupuncture
Applicant	Wuxi Jiajian Medical Instrument Co., Ltd No. 35 Baiqiao Rd., Ehu Town, Xishan District, Wuxi 214116 CN Other 510(k) Applications for this Company
Contact	Caihong Sun Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	BWK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2020
Decision Date	08/27/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review