FDA.reportPublic FDA data

DARCO® GentleStep™ Shoe

Primary DI
00609271230583
Brand
DARCO® GentleStep™ Shoe
Company
DARCO INTERNATIONAL, INC.
Model
GS055XB
Catalog number
GS055XB
Device description
Women's 5.5 / Men's 4 Black Extra-wide width
Published
2023-02-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KNPORTHOSIS, CORRECTIVE SHOE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNPOrthosis, Corrective ShoePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20609271230587PackageGS18In Commercial Distribution
00609271230583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2060927123058720609271230587
00609271230583006092712305836092712305830609271230583

GMDN Terms#

Term, Definition table
TermDefinition
Orthotic shoe, non-customizedA prefabricated (non-customized) footwear designed as a shoe intended to support, align, prevent, and compensate for or correct deformities of the feet to help improve function and/or for post-operative therapy. This is a reusable device.

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
00609271120297POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120334POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120501POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271000353KERRAPED PLUS™ All Purpose BootDarco (Europe) GmbHKNP2023-02-13
00609271000360KERRAPED PLUS™ All Purpose BootDarco (Europe) GmbHKNP2023-02-13
00609271000377KERRAPED PLUS™ All Purpose BootDarco (Europe) GmbHKNP2023-02-13
00609271000384KERRAPED PLUS™ All Purpose BootDarco (Europe) GmbHKNP2023-02-13
00609271001428DARCO® Relief Dual® PlusDarco (Europe) GmbHKNP2023-02-13
00609271001435DARCO® Relief Dual® PlusDarco (Europe) GmbHKNP2023-02-13
00609271001442DARCO® Relief Dual® PlusDarco (Europe) GmbHKNP2023-02-13
00609271001459DARCO® Relief Dual® PlusDarco (Europe) GmbHKNP2023-02-13
00609271001466DARCO® Relief Dual® PlusDarco (Europe) GmbHKNP2023-02-13
00609271001473DARCO® Relief Dual® PlusDarco (Europe) GmbHKNP2023-02-13
00609271001480DARCO® Relief Dual® PlusDarco (Europe) GmbHKNP2023-02-13
00609271001497DARCO® Relief Dual® PlusDarco (Europe) GmbHKNP2023-02-13
00609271010116DARCO® Medical-surgical shoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271010215DARCO® Medical-surgical shoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271010314DARCO® Medical-surgical shoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271010413DARCO® Medical-surgical shoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271013117DARCO® Medical-surgical shoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271013216DARCO® Medical-surgical shoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271013315DARCO® Medical-surgical shoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271016514DARCO® Medical-surgical shoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271230569DARCO® GentleStep™ ShoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271230576DARCO® GentleStep™ ShoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271230613DARCO® GentleStep™ ShoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271230620DARCO® GentleStep™ ShoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271230637DARCO® GentleStep™ ShoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271230668DARCO® GentleStep™ ShoeDARCO INTERNATIONAL, INC.KNP2023-02-13
00609271230675DARCO® GentleStep™ ShoeDARCO INTERNATIONAL, INC.KNP2023-02-13