FDA.reportPublic FDA data

InhwRior

Primary DI
06978785665087
Brand
InhwRior
Company
Shenzhen Yuechuan trade Co., Ltd.
Model
JGYJZQ-02
Device description
The Ingrown Toenail Corrector YC02 is primarily intended for personal daily foot care in the home environment.
Published
2025-12-08
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
06978785665087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06978785665087069787856650876978785665087

GMDN Terms#

Term, Definition table
TermDefinition
Ingrowing toenail splinting kitA collection of non-sterile devices intended to treat ingrowing toenail and the associated pain by lifting the nail at the outer edges to encourage the nail to grow out naturally beyond the hyponichium. It includes a toenail splint(s), adhesive, and typically additional support devices (e.g., cooling spray to relieve pain). The splint is a small device with a clip intended to be adhered to the top of the toenail, clipped under the nail to prevent ingrowth, and left in place (e.g., for a period of days). It is normally available [non-prescription] over-the-counter (OTC) for use in the home. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
450549961
Device count
1
Premarket exempt
true
Kit
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
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
06978785665025InhwRiorYC-FZJZQ-0022025-07-09
06978785665032InhwRiorYC-JGYJZQ-0032025-07-09
16978785665046InhwRiorYC-ZJBHL-0042025-07-09
06978785665049InhwRiorYC-ZJBHL-0042025-07-09

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Primary DI, Brand, Company table
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00609271000384KERRAPED PLUS™ All Purpose BootDarco (Europe) GmbHKNP2023-02-13
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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
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00609271230668DARCO® GentleStep™ ShoeDARCO INTERNATIONAL, INC.KNP2023-02-13