FDA 510(k) Application Details - K233098

Device Classification Name	Stimulator, Muscle, Powered   More FDA Info for this Device
510(K) Number	K233098
Device Name	Stimulator, Muscle, Powered
Applicant	SunMed LLC. 2710 Northridge Dr. NW, Suite A Grand Rapids, MI 49544 US Other 510(k) Applications for this Company
Contact	Robert Yamashita 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	09/26/2023
Decision Date	08/02/2024
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