FDA 510(k) Application Details - K223027

Device Classification Name	Stimulator, Muscle, Powered   More FDA Info for this Device
510(K) Number	K223027
Device Name	Stimulator, Muscle, Powered
Applicant	NeuroTrigger Nirim 3 Tel Aviv 67060 IL Other 510(k) Applications for this Company
Contact	Nikolai Kuincher Other 510(k) Applications for this Contact
Regulation Number	890.5850   More FDA Info for this Regulation Number
Classification Product Code	IPF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2022
Decision Date	10/10/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review