FDA.reportPublic FDA data

Legacy IPC

Primary DI
05065012360097
Brand
Legacy IPC
Company
IG TECHNOLOGY LIMITED
Model
v1
Catalog number
001-000
Device description
The Legacy® IPC is a prescription device intended for the prophylaxis of Deep Vein Thrombosis (DVT), stimulating venous and arterial circulation, aiding in the prevention of venous stasis ulcers, aiding in the healing of cutaneous ulcers, reducing acute/chronic edema and compartmental pressures. For use in home or hospital settings.
Published
2025-07-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
JOWSleeve, Limb, Compressible

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOWSleeve, Limb, CompressibleCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232006000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232006000LEGACY® IPCIg Technology, Ltd.2023-08-04JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05065012360097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05065012360097050650123600975065012360097

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent venous compression systemA system used for the noninvasive treatment and prevention of venous disorders and sequelae such as oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE). It functions by intermittently applying pressure to a patient's arms or legs to promote venous blood flow at timed intervals. This is achieved through the cyclical inflation and deflation of a single-chambered stocking, sleeve, or suit applied to the extremities. The system typically consists of a compression pump, control and timing mechanism, tubing, and pneumatic stocking(s) or suit.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Fahrenheit113 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
228348276
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00672736141649BREGBREG, INC.JOW2026-06-25
10193489024500MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-05-18
10193489024531MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-05-18
04719893351026WellellWellell Inc.JOW2026-03-17
08809802648494DVT-SERIESDAESUNG MAREF CO.,LTD.JOW2026-02-09
08809802648500DVT-SERIESDAESUNG MAREF CO.,LTD.JOW2026-02-09
08809802646810DVT-2600DAESUNG MAREF CO.,LTD.JOW2025-12-19
08809802646858DVT-4000SDAESUNG MAREF CO.,LTD.JOW2025-12-19
10080196138302MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-10-14
10193489097252MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-10-13
10192253057775CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057782CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057799CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057805CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057812CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057829CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10193489003154MEDLINE RENEWALMEDLINE INDUSTRIES, INC.JOW2025-04-17
10193489003161MEDLINE RENEWALMEDLINE INDUSTRIES, INC.JOW2025-03-21
10080196391974MEDLINE RENEWALMEDLINE INDUSTRIES, INC.JOW2025-03-18
10197344104543MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-03-11
10192253057768CARDINAL HEALTHCardinal Health 200, LLCJOW2025-02-19
10080196385409MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-01-02
10192253016123Kendall SCDCardinal Health 200, LLCJOW2024-12-16
10192253016130Kendall SCDCardinal Health 200, LLCJOW2024-12-16
10192253016185Kendall SCDCardinal Health 200, LLCJOW2024-12-16
10197344098415MEDLINEMEDLINE INDUSTRIES, INC.JOW2024-12-02
10197344006687MEDLINEMEDLINE INDUSTRIES, INC.JOW2024-11-22
10192253057737CARDINAL HEALTHCardinal Health 200, LLCJOW2024-10-02
10885380184895CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25
10885380184901CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25