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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K131222
FOIA Releasable 510(k) K131222
Device Name AMPCARE ESP THERAPY SYSTEM
Applicant
Ampcare, LLC
1201 Richardson Dr., Suite 280
Richardson,  TX  75080
Applicant Contact DIANE RUTHERFORD
Correspondent
Ampcare, LLC
1201 Richardson Dr., Suite 280
Richardson,  TX  75080
Correspondent Contact DIANE RUTHERFORD
Regulation Number890.5850
Classification Product Code
IPF  
Date Received04/30/2013
Decision Date 10/31/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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