FDA.reportPublic FDA data

Air Compression Therapy Device

Primary DI
06959557201337
Brand
Air Compression Therapy Device
Company
SHENZHEN FUTURE ELECTRONIC CO.,LTD
Model
ST-504
Published
2026-03-31
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
K251662000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251662000Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air Compression Therapy Device (ST-506); Air Compression Therapy Device (ST-507)Shenzhen Future Electronic Co., Ltd.2025-11-13IRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06959557201344PackageGS14In Commercial Distribution
06959557201337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06959557201344069595572013446959557201344
06959557201337069595572013376959557201337

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.

Regulatory Flags#

DUNS number
528197534
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06959557201320Air Compression Therapy DeviceST-5042026-03-31
06959557200354Transcutaneous Electrical Nerve StimulatorST-3042022-09-30
06959557200606Air Compression Therapy DeviceST-5022022-09-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809040526691AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
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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
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08809802644526LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
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