FDA 510(k) Application Details - K202317

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K202317
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	Everyway Medical Instruments Co., Ltd. 3FL., No. 5, Lane 155, Section 3, Peishen Rd., Shenkeng District, New Taipei City 22203 CN 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	08/17/2020
Decision Date	11/13/2020
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