FDA.reportPublic FDA data

EXTENSION ZIPPER

Primary DI
08809277423213
Brand
EXTENSION ZIPPER
Company
WONJIN MULSAN CO.LTD
Model
POWER-Q1000PREMIUM
Device description
EXTENSION ZIPPER for POWER Q1000 PREMIUM
Published
2019-03-04
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
K113275000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113275000COMPRESSIBLE LIMB THERAPY SYSTEMWonjin Mulsan Co., Ltd.2012-02-27IRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18809277423210PackageGS110In Commercial Distribution
28809277423217PackageGS120In Commercial Distribution
38809277423214PackageGS130In Commercial Distribution
48809277423211PackageGS140In Commercial Distribution
58809277423218PackageGS150In Commercial Distribution
88809277423219PackageGS1100In Commercial Distribution
08809277423213PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880927742321018809277423210
2880927742321728809277423217
3880927742321438809277423214
4880927742321148809277423211
5880927742321858809277423218
8880927742321988809277423219
08809277423213088092774232138809277423213

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809277420441POWER-Q1000PREMIUMPOWER-Q1000PREMIUM2016-08-19
08809277421677SINGLE HOSE WHF-3242019-04-18
08809277423466WONJINPOWER-Q23002022-01-11
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

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Primary DI, Brand, Company table
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