FDA.reportPublic FDA data

InhwRior

Primary DI
06978785665025
Brand
InhwRior
Company
Shenzhen Yuechuan trade Co., Ltd.
Model
YC-FZJZQ-002
Device description
Maintains alignment after congenital toe deformity corrections
Published
2025-07-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
06978785665025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06978785665025069787856650256978785665025

GMDN Terms#

Term, Definition table
TermDefinition
Nail fungus treatment kit, medicatedA collection of devices which includes a pharmaceutical intended to be used as a procedure pack for the treatment of fungal infection (onychomycosis) of the fingernail(s) and toenail(s). It includes devices such as a urea ointment, pharmaceutical antifungal (e.g., bifonazole) cream, a plastic nail scraper, and adhesive bandages. The procedure involves gradual softening and subsequent removal of the nail before treating the nail bed by topical application of the antifungal cream. It is normally available for patient/layperson use in the home. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
450549961
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06978785665070InhwRiorZJNJ2025-12-08
06978785665087InhwRiorJGYJZQ-022025-12-08
06978785665094InhwRiorJGYJZQ-032025-12-08
06978785665100InhwRiorRCD2025-12-08
06978785665117InhwRiorXBY2025-12-08
06978785665124InhwRiorXBY2025-12-08
06978785665131InhwRiorJQ-S14U-XBY2025-12-08
06978785665148InhwRiorJQ-CO9-XBY2025-12-08
06978785665056InhwRiorJQ-C092025-08-08
06978785665063InhwRiorJQ-S14U2025-08-08
26978785665043InhwRiorYC-ZJBHL-0042025-07-09
06978785665018InhwRiorYC-CDCJ-0012025-07-09
06978785665032InhwRiorYC-JGYJZQ-0032025-07-09
16978785665046InhwRiorYC-ZJBHL-0042025-07-09
06978785665049InhwRiorYC-ZJBHL-0042025-07-09

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