FDA 510(k) Application Details - K202693

Device Classification Name	Massager, Powered Inflatable Tube   More FDA Info for this Device
510(K) Number	K202693
Device Name	Massager, Powered Inflatable Tube
Applicant	Eva Medtec, Inc 6300 W. Old Shakopee Road, Suite 140 Bloomington, MN 55438 US Other 510(k) Applications for this Company
Contact	Irene Waldridge 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	09/15/2020
Decision Date	03/05/2021
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