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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
510(k) Number K252963
Device Name BTL-899TT
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 Number890.5290
Classification Product Code
IMJ  
Date Received09/17/2025
Decision Date 06/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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