FDA 510(k) Application Details - K013061

Device Classification Name	Massager, Powered Inflatable Tube   More FDA Info for this Device
510(K) Number	K013061
Device Name	Massager, Powered Inflatable Tube
Applicant	TACTILE SYSTEMS TECHNOLOGY INC 1074 LEGION ST. SHAKOPEE, MN 55379 US Other 510(k) Applications for this Company
Contact	ERIC MCKEE 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	09/11/2001
Decision Date	07/01/2002
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