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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 K820080
Device Name BX-1000 ISOMATIC
Applicant
Bloomex International, Inc.
7600 Ridge Blvd Brooklun,  NY 
Correspondent
Bloomex International, Inc.
7600 Ridge Blvd Brooklun,  NY 
Regulation Number890.5850
Classification Product Code
IPF  
Date Received01/12/1982
Decision Date 07/01/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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