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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 K192114
Device Name Game Ready GRPro 2.1 System
Applicant
Cool Systems, Inc. (dba Game Ready)
1800 Sutter Street, Suite 500
concord,  CA  94520
Applicant Contact natalie kennel
Correspondent
NJK & Associates
13721 Via Tres Vista
san diego,  CA  92129
Correspondent Contact natalie kennel
Regulation Number890.5650
Classification Product Code
IRP  
Subsequent Product Code
ILO  
Date Received08/06/2019
Decision Date 10/29/2019
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
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