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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 K221654
Device Name medi pneumatic compression system (pcs)-genius (Model 652)
Applicant
medi USA, L.P.
6481 Franz Warner Parkway
Whitsett,  NC  27377 -9214
Applicant Contact Moses Lipshaw
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number870.5800
Classification Product Code
JOW  
Date Received06/07/2022
Decision Date 07/07/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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