FDA.reportPublic FDA data

Compression Stocking

Primary DI
G4203011
Brand
Compression Stocking
Company
Gottfried Medical, Inc.
Model
301
Catalog number
301
Device description
Waist One Leg Open Crotch
Published
2026-06-04
Public version status
New
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
DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)
FQLStocking, Medical Support (For General Medical Purposes)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)General Hospital2
FQLStocking, Medical Support (For General Medical Purposes)General Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K823737000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K823737000MADE-TO-MEASURE SURGICAL ELASTIC SUPPORTGotfried Medical, Inc.1983-01-12DWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G4203011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure shirt/pantsA garment in the form of a vest, shirt, pants, leggings, girdle, or whole-body suit intended to tightly fit over, and apply compression/pressure (i.e., graduated or even-force) to, an area of the upper and/or mid/lower body to support skin/subcutaneous healing and scar prevention, to exude excessive interstitial fluid, and/or to help improve proprioception. Designed to be worn around the hips and/or shoulders, it is neither a strip/roll binder, limb sleeve, glove, nor sock. It is not intended to come into direct contact with, or to manage/treat, open wounds, injured skin, or infectious or infection-susceptible skin conditions. This is a reusable device.

Regulatory Flags#

DUNS number
038706180
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
G4200211Compression Stocking0210212026-06-04
G4200221Compression Stocking0220222026-06-04
G4201011Compression Stocking1012026-06-04
G4201021Compression Stocking1021022026-06-04
G4201031Compression Stocking1031032026-06-04
G4201041Compression Stocking1041042026-06-04
G4201061Compression Stocking1061062026-06-04
G4202011Compression Stocking2012012026-06-04
G4202021Compression Stocking2022022026-06-04
G4203001Compression Stocking3003002026-06-04
G4203021Compression Stocking3023022026-06-04
G4203031Compression Stocking3033032026-06-04
G4203041Compression Stocking3043042026-06-04
G4203051Compression Stocking3053052026-06-04
G4203061Compression Stocking3063062026-06-04
G4203071Compression Stocking3073072026-06-04
G4203081Compression Stocking3083082026-06-04
G4203091Compression Stocking3093092026-06-04
G4203311Compression Stocking3313312026-06-04
G4203321Compression Stocking3323322026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G4200211Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4200211Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4200221Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4201011Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4201011Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4201021Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4201021Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4201031Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4201031Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4201041Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4201041Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4201061Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4201061Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4202011Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4202011Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4202021Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4202021Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203001Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203001Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203021Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203021Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203031Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203031Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203041Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203041Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203051Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203051Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203061Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203061Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203071Compression StockingGottfried Medical, Inc.DWL2026-06-04