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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biofeedback
510(k) Number K854208
Device Name THE BODYLOG 500 RET THERAPEUTIC ELECTROMYOGRAPHICS
Applicant
Bodylog, Inc.
120 Kisco Ave.
Mt. Kisco,  NY  10549
Applicant Contact STEVEN GOLDMAN
Correspondent
Bodylog, Inc.
120 Kisco Ave.
Mt. Kisco,  NY  10549
Correspondent Contact STEVEN GOLDMAN
Regulation Number882.5050
Classification Product Code
HCC  
Date Received10/17/1985
Decision Date 01/14/1986
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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