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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 K040306
Device Name HIGH VOLTAGE PULSED STIMULATOR, MODEL BMLS02-7
Applicant
Biomedical Life Systems, Inc.
P.O. Box 1360
Vista,  CA  92085
Applicant Contact GARY BUSSETT
Correspondent
Biomedical Life Systems, Inc.
P.O. Box 1360
Vista,  CA  92085
Correspondent Contact GARY BUSSETT
Regulation Number890.5850
Classification Product Code
IPF  
Date Received02/09/2004
Decision Date 03/23/2004
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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