FDA 510(k) Application Details - K200088

Device Classification Name	Stimulator, Muscle, Powered   More FDA Info for this Device
510(K) Number	K200088
Device Name	Stimulator, Muscle, Powered
Applicant	g.tec medical engineering GmbH Siemingerstrasse 14 Schiedlberg 4521 AT Other 510(k) Applications for this Company
Contact	Christoph Guger 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	01/15/2020
Decision Date	10/29/2020
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