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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 K851946
Device Name REMOTE SPEED CONTROL
Applicant
Th Charters, Inc.
9985 SW Heather Ln.
Beaverton,  OR  97008
Applicant Contact THOMAS H CHARTERS
Correspondent
Th Charters, Inc.
9985 SW Heather Ln.
Beaverton,  OR  97008
Correspondent Contact THOMAS H CHARTERS
Regulation Number890.5360
Classification Product Code
ISD  
Date Received05/03/1985
Decision Date 07/19/1985
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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