FDA 510(k) Application Details - K193276

Device Classification Name	Stimulator, Neuromuscular, External Functional   More FDA Info for this Device
510(K) Number	K193276
Device Name	Stimulator, Neuromuscular, External Functional
Applicant	Shenzhen XFT Medical Limited Room 203, Building 1, Biomedicine Innovations Industrial Park, #14 Jinhui Road Shenzhen 518118 CN Other 510(k) Applications for this Company
Contact	Julia Ye Other 510(k) Applications for this Contact
Regulation Number	882.5810   More FDA Info for this Regulation Number
Classification Product Code	GZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/26/2019
Decision Date	09/23/2020
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