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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 K241516
Device Name BTL-398
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 Number876.5320
Classification Product Code
KPI  
Date Received05/29/2024
Decision Date 02/10/2025
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
Predetermined Change
Control Plan Authorized		 No
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