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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 K834098
Device Name STATIONARY EXERCISE BICYCLE
Applicant
Engineering Dynamics Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Engineering Dynamics Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5360
Classification Product Code
ISD  
Date Received11/28/1983
Decision Date 12/27/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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