FDA 510(k) Application Details - K171685

Device Classification Name	Massager, Powered Inflatable Tube   More FDA Info for this Device
510(K) Number	K171685
Device Name	Massager, Powered Inflatable Tube
Applicant	Cool Systems, Inc. (dba Game Ready) 1800 Sutter Street, Suite 500 Concord, CA 94520 US Other 510(k) Applications for this Company
Contact	Natalie Kennel Other 510(k) Applications for this Contact
Regulation Number	890.5650   More FDA Info for this Regulation Number
Classification Product Code	IRP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/07/2017
Decision Date	09/29/2017
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