FDA.reportPublic FDA data

EXTENSION ZIPPER

Primary DI
38809277423214
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
OTC
false
Sterile
false
Single use
false

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
88809277423219PackageGS180In 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 pumpAn electrically-powered device 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 with the necessary pressure to promote venous blood flow. This is achieved through the sequential inflation and deflation of the multi-chambered stocking/sleeve/suit applied to the extremities. 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690287912
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
08809277423466WONJINPOWER-Q23002022-01-11
08809277420014POWER-Q1000WHF-3142016-08-19
08809277420885POWER-Q1000PLUSWHF-3242019-04-17
18809277423470WONJINPOWER-Q23002022-01-11
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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08809040526776Air Relax Classic Model AR-1.0 ControlUnit OnlyMaxstar Industrial Co.,Ltd.IRP2025-10-01
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08809040526806Air Relax Classic Model AR-1.0 Leg Recovery System-Size 4Maxstar Industrial Co.,Ltd.IRP2025-10-01
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