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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Equipment, Traction, Powered
510(k) Number K243775
Device Name True Non-Surgical Spinal Decompression System (DRX9000-SL)
Applicant
Excite Medical of Tampa Bay, LLC
4710 Eisenhower Blvd. N Suite A-12
Tampa,  FL  33634
Applicant Contact Saleem Musallam
Correspondent
Cofactor Technologies, Inc.
2002 Blind Pond Ave.
Lutz,  FL  33549
Correspondent Contact Jon Werner
Regulation Number890.5900
Classification Product Code
ITH  
Date Received12/09/2024
Decision Date 07/18/2025
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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