FDA 510(k) Application Details - K080134

Device Classification Name	Massager, Powered Inflatable Tube   More FDA Info for this Device
510(K) Number	K080134
Device Name	Massager, Powered Inflatable Tube
Applicant	WONJIN MULSAN CO., LTD. 155 FLEMINGTON COURT LA MIRADA, CA 90638 US Other 510(k) Applications for this Company
Contact	BRANDON CHOI 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	01/18/2008
Decision Date	01/23/2009
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