FDA 510(k) Application Details - K192087

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K192087
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	Shenzhen Roundwhale Technology Co., Ltd. 202, 2/F, Building 27, Dafa Industrial Park Longxi Community, Longgang Street Shenzhen 518108 CN Other 510(k) Applications for this Company
Contact	Kevin 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	08/05/2019
Decision Date	11/01/2019
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