FDA.reportPublic FDA data

POWER-Q1000

Primary DI
08809277420014
Brand
POWER-Q1000
Company
WONJIN MULSAN CO.LTD
Model
WHF-314
Device description
Sequential venous compression system pump,A powered inflatable tube massager
Published
2016-08-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K080134000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080134000COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, MODEL WHF-314 (POWER-Q1000)Wonjin Mulsan Co., Ltd.2009-01-23IRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18809277426020PackageGS11In Commercial Distribution
28809277426027PackageGS12In Commercial Distribution
38809277426024PackageGS13In Commercial Distribution
48809277426021PackageGS14In Commercial Distribution
08809277420014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880927742602018809277426020
2880927742602728809277426027
3880927742602438809277426024
4880927742602148809277426021
08809277420014088092774200148809277420014

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

Contacts#

Phone, Email table
PhoneEmail
1-516-376-2537wonjin@wonjininc.com

Regulatory Flags#

DUNS number
690287912
Device count
1
Serial number
true
Manufacturing date on label
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
08809277423466WONJINPOWER-Q23002022-01-11
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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