FDA 510(k) Application Details - K190988

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K190988
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	Gemore Technology Co Ltd 11FL., No.29-5, Sec.2, Chug Cheng E. RD., Tan Shui, New Taipei City 251 TW Other 510(k) Applications for this Company
Contact	Boden S.P. Lai 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	04/15/2019
Decision Date	08/16/2019
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