FDA 510(k) Application Details - K200558

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K200558
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	GUANDONG SKG INTELLIGENT TECHNOLOGY CO., LTD No.1, 7/F, Yingfeng Business Center, No.8 Yixing Road, Beijiao Town Shunde District, Foshan City 528303 CN Other 510(k) Applications for this Company
Contact	Mao Hui Zhang 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	03/03/2020
Decision Date	10/04/2021
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