FDA 510(k) Application Details - K221958

Device Classification Name	Stimulator, Muscle, Powered   More FDA Info for this Device
510(K) Number	K221958
Device Name	Stimulator, Muscle, Powered
Applicant	EMSI, Inc. 3504 Cragmont Sr., Suite 100 Tampa, FL 33619 US Other 510(k) Applications for this Company
Contact	Chad Sagnip 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	07/05/2022
Decision Date	10/21/2022
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