FDA 510(k) Application Details - K231912

Device Classification Name	Massager, Powered Inflatable Tube   More FDA Info for this Device
510(K) Number	K231912
Device Name	Massager, Powered Inflatable Tube
Applicant	Zenith Technical Innovations 1396 St. Paul Ave. Gurnee, IL 60031 US Other 510(k) Applications for this Company
Contact	Greg Binversie 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	06/29/2023
Decision Date	07/27/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review