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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 K160992
Device Name HPM-6000
Applicant
BTL Industries, Inc.
47 Loring Dr.
Framingham,  MA  01702
Applicant Contact JAN ZARSKY
Correspondent
BTL Industries, Inc.
47 Loring Dr.
Framingham,  MA  01702
Correspondent Contact JAN ZARSKY
Regulation Number890.5850
Classification Product Code
IPF  
Date Received04/08/2016
Decision Date 10/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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