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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interactive Rehabilitation Exercise Devices
510(k) Number K033514
Device Name CODA CX1 MOTION ANALYSIS SYSTEM
Applicant
Charnwood Dynamics , Ltd.
Unit 2, Victoria Mills
Fowke St.
Rothley, Leicestershire,  GB LE7 7PJ
Applicant Contact DAVID L MITCHELSON
Correspondent
Charnwood Dynamics , Ltd.
Unit 2, Victoria Mills
Fowke St.
Rothley, Leicestershire,  GB LE7 7PJ
Correspondent Contact DAVID L MITCHELSON
Regulation Number890.5360
Classification Product Code
LXJ  
Date Received11/06/2003
Decision Date 01/06/2004
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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