FDA 510(k) Application Details - K053078

Device Classification Name	Exerciser, Measuring   More FDA Info for this Device
510(K) Number	K053078
Device Name	Exerciser, Measuring
Applicant	ERGOLINE GMBH LINDENSTR. 6 BITZ, B-W 72475 DE Other 510(k) Applications for this Company
Contact	HAIKO BELL Other 510(k) Applications for this Contact
Regulation Number	890.5360   More FDA Info for this Regulation Number
Classification Product Code	ISD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/02/2005
Decision Date	04/27/2006
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	Y
Expedited Review