FDA 510(k) Application Details - K182163

Device Classification Name	Stimulator, Muscle, Powered   More FDA Info for this Device
510(K) Number	K182163
Device Name	Stimulator, Muscle, Powered
Applicant	Shear Stress Therapeutics, LLC 6207 East 78th Place Tulsa, OK 74136 US Other 510(k) Applications for this Company
Contact	John Owen 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	08/10/2018
Decision Date	07/09/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review