FDA 510(k) Application Details - K181199

Device Classification Name	Stimulator, Muscle, Powered, For Muscle Conditioning   More FDA Info for this Device
510(K) Number	K181199
Device Name	Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant	Katalyst Inc. 316 Occidental Ave. South Suite B300 Seattle, WA 98104 US Other 510(k) Applications for this Company
Contact	Bjoern Woltermann Other 510(k) Applications for this Contact
Regulation Number	890.5850   More FDA Info for this Regulation Number
Classification Product Code	NGX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/07/2018
Decision Date	09/20/2018
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