FDA 510(k) Application Details - K003909

Device Classification Name	Massager, Powered Inflatable Tube   More FDA Info for this Device
510(K) Number	K003909
Device Name	Massager, Powered Inflatable Tube
Applicant	PROACT CO. PO BOX 1026 MT PLEASANT, SC 29465-1026 US Other 510(k) Applications for this Company
Contact	JEAN ROZINT 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	12/19/2000
Decision Date	06/13/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review