FDA.reportPublic FDA data

POWER-Q1000

Primary DI
48809277426021
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
OTC
false
Sterile
false
Single use
false

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
38809277426024PackageGS14In Commercial Distribution
48809277426021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1880927742602018809277426020
2880927742602728809277426027
3880927742602438809277426024
4880927742602148809277426021

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
38809277423214EXTENSION ZIPPER POWER-Q1000PREMIUM 2019-03-04
18809277421674SINGLE HOSE WHF-3242019-04-18
38809277420442POWER-Q1000PREMIUMPOWER-Q1000PREMIUM2016-08-19

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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
08809040526783Air Relax Classic Model AR-1.0 Leg Recovery System-Size 2Maxstar Industrial Co.,Ltd.IRP2025-10-01
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