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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 K223164
Device Name Aquilo Sports CCT1500 System
Applicant
Aquilo SPorts LLC
1902 Campus Pl Ste 12
Louisville,  KY  40299
Applicant Contact JP Spence
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number890.5650
Classification Product Code
IRP  
Date Received10/07/2022
Decision Date 11/04/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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