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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K251446
Device Name PlasmaFlow X Compression Sleeve Device (XPF0001)
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 Number870.5800
Classification Product Code
JOW  
Date Received05/09/2025
Decision Date 09/17/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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