FDA.reportPublic FDA data

Aquilo Sports

Primary DI
00850009827333
Brand
Aquilo Sports
Company
Aquilo Sports L.L.C.
Model
CCT1500 System
Published
2024-07-16
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
00850009827333PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850009827333008500098273338500098273330850009827333

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-fluid localized thermal/compression therapy system control unitAn electrically-powered device intended to pump heated and/or cooled water through an externally applied wrap (not included), and to air inflate the wrap, for localized thermal and compression therapy to facilitate the treatment of a variety of adverse conditions resulting from musculoskeletal injury and/or orthopaedic surgery (e.g., pain, swelling, inflammation). It includes a fluid pump, air pump, controls, and either a heater or a means for cold therapy (e.g., refrigeration unit, addition of independently cooled ice water) or both. The unit may be programmable for selected treatment plans. It is intended for use in both professional and home settings.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080077503
Device count
1
Kit
true
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
00850009827340Aquilo SportsFull Leg Sleeve (M) - RightAQU665 CR12025-08-18
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

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