FDA 510(k) Application Details - K230167

Device Classification Name	Stimulator, Muscle, Powered   More FDA Info for this Device
510(K) Number	K230167
Device Name	Stimulator, Muscle, Powered
Applicant	SWIMS America Corp 1133 Westchester Avenue Suite N 220 White Plains, NY 10604 US Other 510(k) Applications for this Company
Contact	Matthieu Commeau 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	01/20/2023
Decision Date	09/14/2023
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