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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 K040007
Device Name INTERFERENTIAL STIMULATOR, MODEL BMLS02-6
Applicant
Biomedical Life Systems, Inc.
2448 Cades Way
P.O. Box 1360
Vista,  CA  92085
Applicant Contact RICHARD SAXON
Correspondent
Biomedical Life Systems, Inc.
2448 Cades Way
P.O. Box 1360
Vista,  CA  92085
Correspondent Contact RICHARD SAXON
Regulation Number882.5890
Classification Product Code
LIH  
Date Received01/02/2004
Decision Date 07/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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