FDA 510(k) Application Details - K223164

Device Classification Name	Massager, Powered Inflatable Tube   More FDA Info for this Device
510(K) Number	K223164
Device Name	Massager, Powered Inflatable Tube
Applicant	Aquilo SPorts LLC 1902 Campus Pl Ste 12 Louisville, KY 40299 US Other 510(k) Applications for this Company
Contact	JP Spence 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	10/07/2022
Decision Date	11/04/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review