FDA.reportPublic FDA data

AIR RELAX

Primary DI
38809040523691
Brand
AIR RELAX
Company
Maxstar Industrial Co.,Ltd.
Model
UAM-8100
Catalog number
UAM-8100
Device description
4 CHAMBER DEVICE
Published
2017-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOWSleeve, Limb, Compressible

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOWSleeve, Limb, CompressibleCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130385000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130385000COMPRESSIBLE LIMB SLEEVE SYSTEMMaxstar Industrial Co., Ltd.2014-02-18IRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38809040523691PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3880904052369138809040523691

GMDN Terms#

Term, Definition table
TermDefinition
Multi-chamber venous compression system garment, reusableAn inflatable device in the form of a stocking, sleeve, or suit that is applied to the limbs externally to promote venous blood flow. As part of a compression system, the device applies pressure to the extremities through the sequential inflation of several chambers. 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. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+82319893543overseas@maxstar.co.kr

Regulatory Flags#

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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