FDA.reportPublic FDA data

Aquilo Sports

Primary DI
00850009827562
Brand
Aquilo Sports
Company
Aquilo Sports L.L.C.
Model
Air Tube - Single
Catalog number
AQU680 AS1
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
00850009827562PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850009827562008500098275628500098275620850009827562

GMDN Terms#

Term, Definition table
TermDefinition
External cuff/pad inflation tubing set, reusableA collection of devices consisting of flexible tubes and connectors, which may also include supportive devices (e.g., clamp), intended to be used to deliver air from a pump to a noninvasive, patient-contact pad, pack, cuff, or cushion. It may be intended for use with a specific type of assembly. 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
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
00850009827319Aquilo SportsCT1000 System2024-08-07
00850009827333Aquilo SportsCCT1500 System2024-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809040526691AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
08809040526707AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
08809040526714AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
08809040526721AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
08809802644885LX9maxDAESUNG MAREF CO.,LTD.IRP2025-11-14
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08809802644908LX9maxDAESUNG MAREF CO.,LTD.IRP2025-11-14
08809802644915LX9maxDAESUNG MAREF CO.,LTD.IRP2025-11-14
08809040526776Air Relax Classic Model AR-1.0 ControlUnit OnlyMaxstar Industrial Co.,Ltd.IRP2025-10-01
08809040526783Air Relax Classic Model AR-1.0 Leg Recovery System-Size 2Maxstar Industrial Co.,Ltd.IRP2025-10-01
08809040526790Air Relax Classic Model AR-1.0 Leg Recovery System-Size 3Maxstar Industrial Co.,Ltd.IRP2025-10-01
08809040526806Air Relax Classic Model AR-1.0 Leg Recovery System-Size 4Maxstar Industrial Co.,Ltd.IRP2025-10-01
08809643652087CERAGEM Master V9CERAGEM Co., Ltd.IRP2025-07-15
08809494000686CERAGEM Master V7CERAGEM Co., Ltd.IRP2025-02-12
08809494000983CERAGEM Master V7CERAGEM Co., Ltd.IRP2025-02-12
08809802644526LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644533LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644540LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644557LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644564LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644571LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644588LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644595LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644601LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644618LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644625LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644632LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644649LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644656LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644663LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20