FDA.reportPublic FDA data

DARCO® HeelWedge™ shoe

Primary DI
10609271829159
Brand
DARCO® HeelWedge™ shoe
Company
DARCO INTERNATIONAL, INC.
Model
HQ1B
Catalog number
HQ1B; HW1B-ST
Device description
Small 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
10609271829159PackageGS112In Commercial Distribution
20609271829156PackageGS136In Commercial Distribution
00609271829152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060927182915910609271829159
2060927182915620609271829156
00609271829152006092718291526092718291520609271829152

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
20609271989607Aircore™ InsoleACIP0602026-01-07
20609271989614Aircore™ InsoleACIP0702026-01-07
20609271989621Aircore™ InsoleACIP0752026-01-07
20609271989638Aircore™ InsoleACIP0802026-01-07
00609271989641Aircore™ InsoleACIP0852026-01-07
20609271989652Aircore™ InsoleACIP0902026-01-07
20609271989669Aircore™ InsoleACIP0952026-01-07
20609271989676Aircore™ InsoleACIP1002026-01-07
20609271989683Aircore™ InsoleACIP1052026-01-07
20609271989690Aircore™ InsoleACIP1102026-01-07
20609271989706Aircore™ InsoleACIP1152026-01-07
20609271989713Aircore™ InsoleACIP1202026-01-07
20609271989720Aircore™ InsoleACIP1252026-01-07
20609271989737Aircore™ InsoleACIP1302026-01-07
20609271989744Aircore™ InsoleACIP1352026-01-07
20609271989751Aircore™ InsoleACIP1452026-01-07
20609271989768Aircore™ InsoleACIP1552026-01-07
00609271120167POGO™ PulsusPGP060NPGP060N2025-04-15
00609271120174POGO™ PulsusPGP070NPGP070N2025-04-15
00609271120181POGO™ PulsusPGP075NPGP075N2025-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178886319CoreTechVIVE HEALTH LLCKNP2026-02-03
00810178886326CoreTechVIVE HEALTH LLCKNP2026-02-03
00810178886333CoreTechVIVE HEALTH LLCKNP2026-02-03
00810178886340CoreTechVIVE HEALTH LLCKNP2026-02-03
00810178886357CoreTechVIVE HEALTH LLCKNP2026-02-03
00810178886364CoreTechVIVE HEALTH LLCKNP2026-02-03
00810060888582Mitchell Ponseti® Bracing SystemMD ORTHOPAEDICS, INC.KNP2025-12-15
00810060888599Mitchell Ponseti® Bracing SystemMD ORTHOPAEDICS, INC.KNP2025-12-15
00810060888605Mitchell Ponseti® Bracing SystemMD ORTHOPAEDICS, INC.KNP2025-12-15
06978785665087InhwRiorShenzhen Yuechuan trade Co., Ltd.KNP2025-12-08
06978785665094InhwRiorShenzhen Yuechuan trade Co., Ltd.KNP2025-12-08
00810195430755CadenseCadense, Inc.KNP2025-08-18
06978785665025InhwRiorShenzhen Yuechuan trade Co., Ltd.KNP2025-07-09
10810178880161ViveVIVE HEALTH LLCKNP2025-07-08
10810178880178ViveVIVE HEALTH LLCKNP2025-07-08
10810178880185ViveVIVE HEALTH LLCKNP2025-07-08
10810178880192ViveVIVE HEALTH LLCKNP2025-07-08
10810178880208ViveVIVE HEALTH LLCKNP2025-07-08
00810195430557CadenseCadense, Inc.KNP2025-07-08
00810195430564CadenseCadense, Inc.KNP2025-07-08
00810195430571CadenseCadense, Inc.KNP2025-07-08
00810195430588CadenseCadense, Inc.KNP2025-07-08
00609271120167POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120174POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120181POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120198POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120204POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120211POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120228POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120235POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15