FDA 510(k) Application Details - K212149

Device Classification Name	Stimulator, Neuromuscular, External Functional   More FDA Info for this Device
510(K) Number	K212149
Device Name	Stimulator, Neuromuscular, External Functional
Applicant	MyndTec Inc. 1900 Minnesota Court Suite 122 Mississauga CA Other 510(k) Applications for this Company
Contact	Yesmil Pena 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	07/09/2021
Decision Date	03/03/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review