Aquilo Sports CCT1500 System

Massager, Powered Inflatable Tube

Aquilo SPorts LLC

The following data is part of a premarket notification filed by Aquilo Sports Llc with the FDA for Aquilo Sports Cct1500 System.

Pre-market Notification Details

Device IDK223164
510k NumberK223164
Device Name:Aquilo Sports CCT1500 System
ClassificationMassager, Powered Inflatable Tube
Applicant Aquilo SPorts LLC 1902 Campus Pl Ste 12 Louisville,  KY  40299
ContactJP Spence
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeIRP  
CFR Regulation Number890.5650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2022-10-07
Decision Date2022-11-04

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