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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 K190456
Device Name BTL 799-2L
Applicant
BTL Industries, Inc.
362 Elm St.
Marlborough,  MA  01752
Applicant Contact David Chmel
Correspondent
BTL Industries, Inc.
362 Elm St.
Marlborough,  MA  01752
Correspondent Contact David Chmel
Regulation Number890.5850
Classification Product Code
NGX  
Date Received02/25/2019
Decision Date 07/05/2019
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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