FDA 510(k) Application Details - K213925

Device Classification Name	Stimulator, Neuromuscular, External Functional   More FDA Info for this Device
510(K) Number	K213925
Device Name	Stimulator, Neuromuscular, External Functional
Applicant	Myolyn, LLC 6931 NW 22nd Street, Suite A Gainesville, FL 32653-1231 US Other 510(k) Applications for this Company
Contact	Matthew Bellman 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	12/16/2021
Decision Date	04/25/2022
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