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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 K143512
Device Name ActiSpec Activity Monitor
Applicant
Sleep Modus, Inc.
1201 Richardson Dr., Suite 280-B
Richardson,  TX  75080
Applicant Contact STANFORD P HUDSON
Correspondent
Ken Block Consulting
1201 Richardson Dr., Suite 280
Richardson,  TX  75080
Correspondent Contact DIANE RUTHERFORD
Regulation Number890.5360
Classification Product Code
ISD  
Date Received12/11/2014
Decision Date 08/26/2015
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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