FDA.reportPublic FDA data

Aquilo Sports

Primary DI
00850009827340
Brand
Aquilo Sports
Company
Aquilo Sports L.L.C.
Model
Full Leg Sleeve (M) - Right
Catalog number
AQU665 CR1
Published
2025-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IRPMassager, Powered Inflatable Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRPMassager, Powered Inflatable TubePhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223164000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223164000Aquilo Sports CCT1500 SystemAquilo Sports, LLC2022-11-04IRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850009827340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850009827340008500098273408500098273400850009827340

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-fluid localized thermal/compression therapy system wrapA non-sterile component of a circulating-fluid localized thermal/compression therapy system intended to facilitate, through thermal therapy (heating and/or cooling) and compression, the treatment of a variety of adverse conditions resulting from a musculoskeletal injury/orthopaedic surgery (e.g., pain, swelling, inflammation). It is intended to be fastened around a single or multiple anatomies and consists of: a heat exchanger, which enables heated and/or cooled fluid from the system control unit to be circulated; and an external sleeve, which enables intermittent compression via inflation. It is intended for use in both professional and home settings. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080077503
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850009827272Aquilo SportsAir Tube - DualAQU655 AT22025-08-18
00850009827357Aquilo SportsFull Leg Sleeve (M) - LeftAQU666 CL12025-08-18
00850009827388Aquilo SportsFull Leg Sleeve (L) - LeftAQU669 CL22025-08-18
00850009827395Aquilo SportsFull Leg Sleeve (L) - RightAQU670 CR22025-08-18
00850009827425Aquilo SportsKnee Wrap - LeftAQU673 KW12025-08-18
00850009827432Aquilo SportsAnkle Wrap - LeftAQU674 AW12025-08-18
00850009827456Aquilo SportsAnkle Wrap - RightAQU675 AW22025-08-18
00850009827463Aquilo SportsKnee Wrap - RightAQU676 KW22025-08-18
00850009827562Aquilo SportsAir Tube - SingleAQU680 AS12025-08-18
00850009827319Aquilo SportsCT1000 System2024-08-07
00850009827333Aquilo SportsCCT1500 System2024-07-16

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Primary DI, Brand, Company table
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