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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 K960457
Device Name ELECTRONIC MUSCLE STIMULATOR MODEL EMS-1C/EMS-2C
Applicant
Med Labs, Inc.
28 Vereda Cordillera
Goleta,  CA  93117
Applicant Contact GLORIA NORVELL
Correspondent
Med Labs, Inc.
28 Vereda Cordillera
Goleta,  CA  93117
Correspondent Contact GLORIA NORVELL
Regulation Number890.5850
Classification Product Code
IPF  
Date Received01/30/1996
Decision Date 09/06/1996
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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