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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interferential Current Therapy
510(k) Number K942428
Device Name CMT-1000
Applicant
Ems, Inc.
P.O. Drawer 179
Pen Valley,  CA  95946
Applicant Contact THOMAS DAIGLE
Correspondent
Ems, Inc.
P.O. Drawer 179
Pen Valley,  CA  95946
Correspondent Contact THOMAS DAIGLE
Regulation Number882.5890
Classification Product Code
LIH  
Date Received05/20/1994
Decision Date 05/23/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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