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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 K080545
Device Name ACTITRAINER
Applicant
Actigraph, LLC
15 W. Main. St.
Pensacola,  FL  32502
Applicant Contact JOHN SCHEIDER
Correspondent
Actigraph, LLC
15 W. Main. St.
Pensacola,  FL  32502
Correspondent Contact John Scheider
Regulation Number890.5360
Classification Product Code
ISD  
Date Received02/27/2008
Decision Date 07/24/2008
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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