FDA.reportPublic FDA data

Health Design Posi Wedge Post Op Shoe

Primary DI
20609271001316
Brand
Health Design Posi Wedge Post Op Shoe
Company
DARCO INTERNATIONAL, INC.
Model
HD-PO-PW2
Catalog number
HD-PO-PW2
Device description
Medium Black
Published
2023-02-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
10609271001319PackageGS112In Commercial Distribution
20609271001316PackageGS136In Commercial Distribution
00609271001312PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060927100131910609271001319
2060927100131620609271001316
00609271001312006092710013126092710013120609271001312

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184231298
Device count
1
DM exempt
false
Premarket exempt
true
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
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
00609271230583DARCO® 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