FDA 510(k) Application Details - K183702

Device Classification Name	Massager, Powered Inflatable Tube   More FDA Info for this Device
510(K) Number	K183702
Device Name	Massager, Powered Inflatable Tube
Applicant	Breg Inc. 2885 Locker Ave. East Carlsbad, CA 92010 US Other 510(k) Applications for this Company
Contact	Monique Zamora 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	12/31/2018
Decision Date	03/01/2019
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