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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, for muscle conditioning
510(k) Number K163165
Device Name AM-100
Applicant
BTL INDUSTRIES, INC
47 Loring Drive
Framington,  MA  01702
Applicant Contact David Chmel
Correspondent
BTL INDUSTRIES, INC
47 Loring Drive
Framington,  MA  01702
Correspondent Contact David Chmel
Regulation Number890.5850
Classification Product Code
NGX  
Date Received11/10/2016
Decision Date 02/16/2017
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
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