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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Powered Inflatable Tube
510(k) Number K260944
Device Name ManaCold Compression System
Applicant
Manamed, LLC
2612 Sirius Dr.
Denton,  TX  76208
Applicant Contact Trevor Theriot
Correspondent
Manamed, LLC
2612 Sirius Dr.
Denton,  TX  76208
Correspondent Contact Trevor Theriot
Regulation Number890.5650
Classification Product Code
IRP  
Subsequent Product Code
ILO  
Date Received03/23/2026
Decision Date 08/12/2026
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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