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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Non-Implantable, For Incontinence
510(k) Number K181497
Device Name HPM-6000UF
Applicant
BTL Industries, Inc.
362 Elm Street
Marlborough,  MA  01752
Applicant Contact David Chmel
Correspondent
BTL Industries, Inc.
362 Elm Street
Marlborough,  MA  01752
Correspondent Contact David Chmel
Regulation Number876.5320
Classification Product Code
KPI  
Date Received06/07/2018
Decision Date 11/14/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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