FDA 510(k) Application Details - K192746

Device Classification Name	Stimulator, Muscle, Powered   More FDA Info for this Device
510(K) Number	K192746
Device Name	Stimulator, Muscle, Powered
Applicant	MyoWorx Inc. 201-77 Westmount Road, Suite 201 Guelph N1H 5J1 CA Other 510(k) Applications for this Company
Contact	Bert Oucharek 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	09/30/2019
Decision Date	10/19/2021
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