FDA 510(k) Application Details - K202893

Device Classification Name	Stimulator, Nerve, Transcutaneous, For Pain Relief   More FDA Info for this Device
510(K) Number	K202893
Device Name	Stimulator, Nerve, Transcutaneous, For Pain Relief
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	882.5890   More FDA Info for this Regulation Number
Classification Product Code	GZJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2020
Decision Date	06/18/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review