FDA.reportPublic FDA data

DARCO® FXPro Walker Liner

Primary DI
00609271789456
Brand
DARCO® FXPro Walker Liner
Company
DARCO INTERNATIONAL, INC.
Model
FXSL4
Catalog number
FXSL4
Device description
XL Black low version
Published
2023-02-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NOCSplint, extremity, non-inflatable, external, non-sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOCSplint, Extremity, Non-Inflatable, External, Non-SterileGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00609271789456PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00609271789456006092717894566092717894560609271789456

GMDN Terms#

Term, Definition table
TermDefinition
Lower-limb orthosis ankle/foot componentA non-powered prefabricated (non-customized) component of an externally applied and wearable lower-limb appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct deformities/injuries (e.g., paralysis) or to improve function of the ankle and/or foot through actions such as alignment, hinge-support, or dorsiflexion assistance. It is intended to provide motion control functionality through a media-free mechanical resistance mechanism [i.e., spring-actuation with no fluid or gas operating media]. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184231298
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
0060927120013516'' DLX POST-OP KNEE IMMOB462-0012-30462-0012-302023-02-08
0060927120015916'' DLX POST-OP KNEE IMMOB462-0012-40462-0012-402023-02-08
0060927120017316'' DLX POST-OP KNEE IMMOB462-0012-50462-0012-502023-02-08
0060927120018016'' DLX POST-OP KNEE IMMOB462-0012-60462-0012-602023-02-08
0060927120019716'' DLX POST-OP KNEE IMMOB462-0012-70462-0012-702023-02-08
0060927120033320'' DLX POST-OP KNEE IMMOB462-0014-30462-0014-302023-02-08
0060927120035720'' DLX POST-OP KNEE IMMOB462-0014-40462-0014-402023-02-08
0060927120037120'' DLX POST-OP KNEE IMMOB462-0014-50462-0014-502023-02-08
0060927120038820'' DLX POST-OP KNEE IMMOB462-0014-60462-0014-602023-02-08
0060927120039520'' DLX POST-OP KNEE IMMOB462-0014-70462-0014-702023-02-08
0060927121050920'' DLX 3-PANEL KNEE IMMOB462-0025-10462-0025-102023-02-08
0060927121060820'' DLX 3-PANEL KNEE IMMOB462-0026-10462-0026-102023-02-08
0060927121080620'' DLX 3-PANEL KNEE IMMOB462-0028-10462-0028-102023-02-08
00609271610774"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (small)"E59410E594102023-02-08
00609271610781"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (medium)"E59411E594112023-02-08
00609271610798"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (large)"E59412E594122023-02-08
00609271610804"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (x-large)"E59413E594132023-02-08
00609271610811"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (small)"E59414E594142023-02-08
00609271610828"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (medium)"E59415E594152023-02-08
00609271610835"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (large)"E59416E594162023-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190446683407PROCAREDJO, LLCNOC2025-07-08
00190446683414PROCAREDJO, LLCNOC2025-07-08
00190446662754PROCAREDJO, LLCNOC2025-07-07
00190446662761PROCAREDJO, LLCNOC2025-07-07
00190446662778PROCAREDJO, LLCNOC2025-07-07
14251853902826Body Armor® PFA WalkerDarco (Europe) GmbHNOC2025-04-15
14251853902833Body Armor® PFA WalkerDarco (Europe) GmbHNOC2025-04-15
14251853902840Body Armor® PFA WalkerDarco (Europe) GmbHNOC2025-04-15
08809818038111Guardian SplintBM KOREA CO., LTDNOC2025-03-20
08809818038128Guardian SplintBM KOREA CO., LTDNOC2025-03-20
08809818038135Guardian SplintBM KOREA CO., LTDNOC2025-03-20
08809818038142Guardian SplintBM KOREA CO., LTDNOC2025-03-20
08809818038159Guardian SplintBM KOREA CO., LTDNOC2025-03-20
08809818038166Guardian SplintBM KOREA CO., LTDNOC2025-03-20
06977071937501MeicenGuangdong Meicen Medical Equipment Co., Ltd.NOC2024-06-21
00810003753700KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753724KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753748KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753762KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753861KENAFLEXXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753885KENAFLEXX KENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753908KENAFLEXXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753922KENAFLEXXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753540KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753564KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753588KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753601KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753625KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753649KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753663KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18