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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Measuring
510(k) Number K053078
Device Name ERGOSELECT 100 K/P, ERGOSELECT 200 K/P
Applicant
Ergoline GmbH
Lindenstr. 6
Bitz, B-W,  DE 72475
Applicant Contact HAIKO BELL
Correspondent
Tuv America, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Regulation Number890.5360
Classification Product Code
ISD  
Date Received11/02/2005
Decision Date 04/27/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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