FDA 510(k) Application Details - K182753

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K182753
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	Everyway Medical Instruments Co., Ltd. 3Fl., No. 5, Lane 155, Sec. 3, Beishen Rd. Shenkeng Dist. New Taipei City 22203 TW Other 510(k) Applications for this Company
Contact	Paul Hung 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	09/28/2018
Decision Date	10/26/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review