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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 K874232
Device Name MUSCLE STIM. DEVICES, BM 2000,4000,6000,8000
Applicant
Health Systems Intl., Inc.
805 King St.
Alexandria,  VA  22314
Applicant Contact BARRY R DIAMOND
Correspondent
Health Systems Intl., Inc.
805 King St.
Alexandria,  VA  22314
Correspondent Contact BARRY R DIAMOND
Regulation Number890.5850
Classification Product Code
IPF  
Date Received10/15/1987
Decision Date 03/10/1989
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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