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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 K112121
Device Name ERGOSELECT/GE
Applicant
Ergoline GmbH
Schwarzwaldstrasse 5
Tuttlingen, Baden Wurttemberg,  DE 78532
Applicant Contact ANDREA PECSI
Correspondent
Ergoline GmbH
Schwarzwaldstrasse 5
Tuttlingen, Baden Wurttemberg,  DE 78532
Correspondent Contact ANDREA PECSI
Regulation Number890.5360
Classification Product Code
ISD  
Date Received07/25/2011
Decision Date 10/31/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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