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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Exerciser, Powered
510(k) Number K844779
Device Name HEALTHMASTER- MODEL 8320 MOTORIZED TREADMILL
Applicant
Roadmaster Corp.
P.O. Box 344
Olney,  IL  62450
Applicant Contact JOE M WILKERSON
Correspondent
Roadmaster Corp.
P.O. Box 344
Olney,  IL  62450
Correspondent Contact JOE M WILKERSON
Regulation Number890.5380
Classification Product Code
BXB  
Date Received12/10/1984
Decision Date 06/28/1985
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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