FDA 510(k) Application Details - K243828

Device Classification Name	Stimulator, Neuromuscular, External Functional   More FDA Info for this Device
510(K) Number	K243828
Device Name	Stimulator, Neuromuscular, External Functional
Applicant	CIONIC Inc. 1500 Green Hills Road Suite 109 Scotts Valley, CA 95066 US Other 510(k) Applications for this Company
Contact	Mihai Ionescu 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	12/13/2024
Decision Date	05/02/2025
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