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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 K251531
Device Name AIR COMPRESSION BOOTS 1018195,1018196
Applicant
Merchsource, LLC
7755 Irvine Center Dr. Suite 100
Irvine,  CA  92618
Applicant Contact Shirley Luo
Correspondent
Merchsource, LLC
7755 Irvine Center Dr. Suite 100
Irvine,  CA  92618
Correspondent Contact Shirley Luo
Regulation Number890.5650
Classification Product Code
IRP  
Date Received05/19/2025
Decision Date 10/30/2025
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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