FDA.reportPublic FDA data

Air Relax Classic Model AR-2.0 Control Unit Only

Primary DI
08809040526813
Brand
Air Relax Classic Model AR-2.0 Control Unit Only
Company
Maxstar Industrial Co.,Ltd.
Model
AR2
Device description
Air Relax Classic Model AR-2.0 Control Unit Only (110V US PLUG - TYPE A)
Published
2021-07-20
Public version status
Update
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
K191441000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191441000Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)Maxstar Industrial Co., Ltd.2021-03-05IRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809040526813PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809040526813088090405268138809040526813

GMDN Terms#

Term, Definition table
TermDefinition
Sequential venous compression system pumpAn electrically-powered device used for the noninvasive treatment and prevention of venous disorders/sequelae. As part of a compression system, the pump provides the connected stocking/sleeve/suit with the necessary pressure to promote venous blood flow. This is achieved through the sequential inflation and deflation of the multi-chambered stocking/sleeve/suit applied to the extremities. It typically consists of a compressor with advanced control/timing mechanism, pressure limiting device, tubing, and connectors. The resulting increased venous blood flow may help to treat/prevent oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE) in non-ambulatory patients or patients at risk.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
687844027
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809040526691AIR RELAX8100N2026-04-27
08809040526707AIR RELAX8100N-S22026-04-27
08809040526714AIR RELAX8100N-S32026-04-27
08809040526721AIR RELAX8100N-S42026-04-27
08809040526776Air Relax Classic Model AR-1.0 ControlUnit OnlyAR12025-10-01
08809040526783Air Relax Classic Model AR-1.0 Leg Recovery System-Size 2AR1-S22025-10-01
08809040526790Air Relax Classic Model AR-1.0 Leg Recovery System-Size 3AR1-S32025-10-01
08809040526806Air Relax Classic Model AR-1.0 Leg Recovery System-Size 4AR1-S42025-10-01
08809040526462Air Relax Pro Model AR-4.0 Control Unit OnlyAR42023-02-08
08809040526479Air Relax Pro Model AR-4.0 Leg Recovery System with a Carrying Case - Size 2AR4-S22023-02-08
08809040526486Air Relax Pro Model AR-4.0 Leg Recovery System with a Carrying Case - Size 3AR4-S32023-02-08
08809040526493Air Relax Pro Model AR-4.0 Leg Recovery System with a Carrying Case - Size 4AR4-S42023-02-08
08809040526509Air Relax Pro Model AR-4.0 Leg Sleeves - Size 2AR4-LS-S22023-02-08
08809040526516Air Relax Pro Model AR-4.0 Leg Sleeves - Size 3AR4-LS-S32023-02-08
08809040526523Air Relax Pro Model AR-4.0 Leg Sleeves - Size 4AR4-LS-S42023-02-08
08809040526530Air Relax Pro Model AR-4.0 Arm Sleeves - Size 1AR4-AS-S12023-02-08
08809040526547Air Relax Pro Model AR-4.0 Arm Sleeves - Size 2AR4-AS-S22023-02-08
08809040526554Air Relax Pro Model AR-4.0 Shorts - Size 1AR4-ST-S12023-02-08
08809040526561Air Relax Pro Model AR-4.0 Shorts - Size 2AR4-ST-S22023-02-08
08809040526578Air Relax Pro Model AR-4.0 Hose BundleAR4-HB2023-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812120004895Game Ready* SystemAvanos Medical, Inc.IRP2026-07-31
00812120005076Game Ready* Full Leg Boot Wrap, MediumAvanos Medical, Inc.IRP2026-07-31
00812120005113Game Ready* Ankle Wrap, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005120Game Ready* Ankle Wrap, Extra LargeAvanos Medical, Inc.IRP2026-07-31
00812120005137Game Ready* Shoulder Wrap, Medium, RightAvanos Medical, Inc.IRP2026-07-31
00812120005144Game Ready* Shoulder Wrap, Medium, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005151Game Ready* Shoulder Wrap, Large, RightAvanos Medical, Inc.IRP2026-07-31
00812120005168Game Ready* Shoulder Wrap, Large, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005175Game Ready* Back WrapAvanos Medical, Inc.IRP2026-07-31
00812120005182Game Ready* C-T Spine Wrap, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005199Game Ready* Hip/Groin Wrap, RightAvanos Medical, Inc.IRP2026-07-31
00812120005205Game Ready* Hip/Groin Wrap, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005212Game Ready* Hand/Wrist WrapAvanos Medical, Inc.IRP2026-07-31
00812120005229Game Ready* Flexed Elbow WrapAvanos Medical, Inc.IRP2026-07-31
00812120005236Game Ready* Half Leg Boot WrapAvanos Medical, Inc.IRP2026-07-31
00812120005243Game Ready* Full Leg Boot Wrap, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005250Game Ready* Straight Knee SleeveAvanos Medical, Inc.IRP2026-07-31
00812120005267Game Ready* Articulated Knee SleeveAvanos Medical, Inc.IRP2026-07-31
00812120005274Game Ready* Straight Elbow SleeveAvanos Medical, Inc.IRP2026-07-31
00812120005281Game Ready* Ankle Sleeve, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005298Game Ready* Ankle Sleeve, Extra LargeAvanos Medical, Inc.IRP2026-07-31
00812120005304Game Ready* Shoulder Sleeve, Medium, RightAvanos Medical, Inc.IRP2026-07-31
00812120005311Game Ready* Shoulder Sleeve, Medium, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005328Game Ready* Shoulder Sleeve, Large, RightAvanos Medical, Inc.IRP2026-07-31
00812120005335Game Ready* Shoulder Sleeve, Large, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005342Game Ready* Back SleeveAvanos Medical, Inc.IRP2026-07-31
00812120005359Game Ready* C-T Spine Sleeve, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005366Game Ready* Hip/Groin Sleeve, RightAvanos Medical, Inc.IRP2026-07-31
00812120005373Game Ready* Hip/Groin Sleeve, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005380Game Ready* Hand/Wrist SleeveAvanos Medical, Inc.IRP2026-07-31