FDA.reportPublic FDA data

Compression Therapy Device

Primary DI
06976287180794
Brand
Compression Therapy Device
Company
Guangzhou Longest Medical Technology Co., Ltd.
Model
LGT-2200SP
Published
2024-07-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K191862000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191862000Compression Therapy Device Model LGT-2200SPGuangzhou Longest Science & Technology Co., Ltd.2019-10-29IRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06976287180794PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976287180794069762871807946976287180794

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent venous compression systemA system used for the noninvasive treatment and prevention of venous disorders and sequelae such as oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE). It functions by intermittently applying pressure to a patient's arms or legs to promote venous blood flow at timed intervals. This is achieved through the cyclical inflation and deflation of a single-chambered stocking, sleeve, or suit applied to the extremities. The system typically consists of a compression pump, control and timing mechanism, tubing, and pneumatic stocking(s) or suit.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
550274189
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06976287180787Active Passive Trainer for Upper and Lower LimbsLGT-5100P2026-04-14
06976287181012Compression Therapy DeviceLGT-2210DS2026-04-14
06976287180336Portable Electro Stimulation Therapy DeviceLGT-2320ME2026-04-02
06976287180343Portable Electro Stimulation Therapy DeviceLGT-2320BE2026-04-02
06976287180350Portable Electro Stimulation Therapy DeviceLGT-2320SP2026-04-02
06976287181005Deep Oscillation Therapy DeviceLGT-2360S2024-09-20
06976287180855Electrostatic Oscillation Therapy DeviceLGT-2360S2024-07-18
06976287180992PowerPulse DeviceLGT-2520AP2024-09-20
06976287180862Radial Pressure Pulse Therapy DeviceLGT-2500S, config II2024-07-22
06976287180879Radial Pressure Pulse Therapy DeviceLGT-2500S, config III2024-07-22
06976287180886Focused Shock Wave Therapy DeviceLGT-2520AP2024-07-22
06976287180466Radial Pressure Pulse Therapy DeviceLGT-2500X2024-07-18
06976287180800Portable Electro-Stimulation Therapy DeviceLGT-231(US)2024-07-18
06976287180817Portable Electro-Stimulation Therapy DeviceLGT-232(US)2024-07-18
06976287180824Portable Electro-Stimulation Therapy DeviceLGT-2332024-07-18
06976287180831Portable Electro-Stimulation Therapy DeviceLGT-235(US)2024-07-18
06976287180848Active Passive Trainer for Upper and Lower LimbsLGT-5100D2024-07-18

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