FDA.reportPublic FDA data

Air Relax Plus Model AR-3.0 Leg Recovery System - Size 4

Primary DI
08809040526400
Brand
Air Relax Plus Model AR-3.0 Leg Recovery System - Size 4
Company
Maxstar Industrial Co.,Ltd.
Model
AR3-S4
Device description
Air Relax Plus Model AR-3.0 Leg Recovery System - Size 4
Published
2021-07-13
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
K211460000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211460000Air Relax Plus Model AR-3.0Diode Art Engineering Doing Business AS Air Relax2021-05-25IRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809040526400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809040526400088090405264008809040526400

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
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
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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
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