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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 K193079
Device Name ICE COMPRESSION FIRST, DUO, & MOOVE Systems
Applicant
Mks Paris
Zone Ecoparc 27 Rue Meziere
Fabregues,  FR 34690
Applicant Contact Cervilla Stanislas
Correspondent
NJK & Associates, Inc.
13721 Via Tres Vista
San Diego,  CA  92129
Correspondent Contact Natalie J. Kennel
Regulation Number890.5650
Classification Product Code
IRP  
Subsequent Product Code
ILO  
Date Received11/05/2019
Decision Date 01/11/2021
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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