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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 K871494
Device Name UPPERCYCLE STATIONARY EXERCISE MACHINES
Applicant
Engineering Dynamics Corp.
120 Stedman St.
Lowell,  MA  01851
Applicant Contact JOHN W LEASK
Correspondent
Engineering Dynamics Corp.
120 Stedman St.
Lowell,  MA  01851
Correspondent Contact JOHN W LEASK
Regulation Number890.5360
Classification Product Code
ISD  
Date Received04/16/1987
Decision Date 05/06/1987
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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