FDA 510(k) Application Details - K221274

Device Classification Name	Stimulator, Muscle, Powered   More FDA Info for this Device
510(K) Number	K221274
Device Name	Stimulator, Muscle, Powered
Applicant	Fotona d.o.o. Stegne 7 Ljubljana 1000 SI Other 510(k) Applications for this Company
Contact	Tina Bartolic 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	05/02/2022
Decision Date	09/29/2023
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