FDA.reportPublic FDA data

InhwRior

Primary DI
06978785665032
Brand
InhwRior
Company
Shenzhen Yuechuan trade Co., Ltd.
Model
YC-JGYJZQ-003
Device description
This device is designed for application to pincer nails (curled nails) or deformed toenails to alleviate pain and improve nail morphology through biomechanical remodeling.
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
ITWJoint, Ankle, External Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITWJoint, Ankle, External BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06978785665032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06978785665032069787856650326978785665032

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
06978785665025InhwRiorYC-FZJZQ-0022025-07-09
16978785665046InhwRiorYC-ZJBHL-0042025-07-09
06978785665049InhwRiorYC-ZJBHL-0042025-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178889723ViveVIVE HEALTH LLCITW2026-05-27
00810178889730ViveVIVE HEALTH LLCITW2026-05-27
00810178889747ViveVIVE HEALTH LLCITW2026-05-27
00810178889754ViveVIVE HEALTH LLCITW2026-05-27
00810178889761ViveVIVE HEALTH LLCITW2026-05-27
00810178889778ViveVIVE HEALTH LLCITW2026-05-27
00810178889785ViveVIVE HEALTH LLCITW2026-05-27
00810178889792ViveVIVE HEALTH LLCITW2026-05-27
00810178889808ViveVIVE HEALTH LLCITW2026-05-27
00810178889815ViveVIVE HEALTH LLCITW2026-05-27
00810178889822ViveVIVE HEALTH LLCITW2026-05-27
00810178889839ViveVIVE HEALTH LLCITW2026-05-27
00810178889846ViveVIVE HEALTH LLCITW2026-05-27
00810178889853ViveVIVE HEALTH LLCITW2026-05-27
00810178889860ViveVIVE HEALTH LLCITW2026-05-27
00810178889877ViveVIVE HEALTH LLCITW2026-05-27
00810178889884ViveVIVE HEALTH LLCITW2026-05-27
00810178889891ViveVIVE HEALTH LLCITW2026-05-27
00810178889907ViveVIVE HEALTH LLCITW2026-05-27
00810178889914ViveVIVE HEALTH LLCITW2026-05-27
00749756880169DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756880183DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756888127DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756888134DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756888141DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756888158DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00810113579801ViveVIVE HEALTH LLCITW2025-05-20
00810113579818ViveVIVE HEALTH LLCITW2025-05-20
00810113579429CoreTechVIVE HEALTH LLCITW2024-10-24
00810113579436CoreTechVIVE HEALTH LLCITW2024-10-24