FDA.reportPublic FDA data

WONJIN

Primary DI
08809277423466
Brand
WONJIN
Company
WONJIN MULSAN CO.LTD
Model
POWER-Q2300
Device description
Sequential venous compressiion system pump, a power inflatable tube massager
Published
2022-01-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K100656000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100656000COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS)Wonjin Mulsan Co., Ltd.2010-05-26IRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18809277423470PackageGS11In Commercial Distribution
28809277423477PackageGS12In Commercial Distribution
38809277423474PackageGS13In Commercial Distribution
48809277423471PackageGS14In Commercial Distribution
08809277423466PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880927742347018809277423470
2880927742347728809277423477
3880927742347438809277423474
4880927742347148809277423471
08809277423466088092774234668809277423466

GMDN Terms#

Term, Definition table
TermDefinition
Sequential venous compression system inflatorAn electrically-powered device intended to be 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 applied to the extremities with the necessary pressure to promote venous blood flow through its sequential inflation and deflation. Also referred to as a pump, 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.

Regulatory Flags#

DUNS number
690287912
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809277420441POWER-Q1000PREMIUMPOWER-Q1000PREMIUM2016-08-19
08809277421677SINGLE HOSE WHF-3242019-04-18
08809277423213EXTENSION ZIPPER POWER-Q1000PREMIUM 2019-03-04
08809277420014POWER-Q1000WHF-3142016-08-19
08809277420885POWER-Q1000PLUSWHF-3242019-04-17
18809277423470WONJINPOWER-Q23002022-01-11
38809277423214EXTENSION ZIPPER POWER-Q1000PREMIUM 2019-03-04
18809277421674SINGLE HOSE WHF-3242019-04-18
38809277420442POWER-Q1000PREMIUMPOWER-Q1000PREMIUM2016-08-19
48809277426021POWER-Q1000WHF-3142016-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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