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510(k) Data Aggregation
K Number
K223164Device Name
Aquilo Sports CCT1500 System
Manufacturer
Date Cleared
2022-11-04
(28 days)
Product Code
Regulation Number
890.5650Why did this record match?
Applicant Name (Manufacturer) :
Aquilo SPorts LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Aquilo Sports CCT1500 System is indicated for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in people who are in good health. The CCT1500 simulates kneading and stroking of tissues by using an inflatable garment.
Device Description
This submission is for the Aquilo Sports CCT1500 System is a powered inflatable tube massager. It is being submitted as an over the counter device. The device is indicated for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in people who are in good health. The CCT1500 simulates kneading and stroking of tissues by using an inflatable garment. The device is a Class II, type BF applied part that receives power a separately approved external IEC 60601-1 compliant power supply or integral battery pack. The CCT1500 consists of an air compressor unit with a control system, an inflatable "boot" for the leg, plastic air tubing with a proprietary connector for connecting the device to the boot. The user interface is a front panel display and buttons. The CCT1500 contains an air compressor with a system control that that allows the user to adjust the amount of air coming from the air compressor and going to the individual segments of the inflatable boot. There is no electrical contact with the user and the device does not transfer or detect energy to or from the user.
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