FDA.reportPublic FDA data

CoreTech

Primary DI
00810041980618
Brand
CoreTech
Company
VIVE HEALTH LLC
Model
SUP2034BLKXL
Device description
4386 Standard Walker Boot (XL)
Published
2022-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
10810041980615PackageGS16In Commercial Distribution
00810041980618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081004198061510810041980615
00810041980618008100419806188100419806180810041980618

GMDN Terms#

Term, Definition table
TermDefinition
Assistive shoes/bootsA device specially designed/adapted to be worn on the feet of a person with a disability for walking and activities (e.g., sport). It is typically constructed with features that facilitate easy donning, fastening, and removal (e.g., special shape, elastic laces).

Regulatory Flags#

DUNS number
047025993
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810178883127ViveSUP3108S2026-07-21
00810178883134ViveSUP3108M2026-07-21
00810178883141ViveSUP3108L2026-07-21
00810178883158ViveSUP3108XL2026-07-21
00810226441217ViveLVA3173WOOD2026-07-21
00810226441224SuresLVA3174BFL2026-07-21
00810226441231SuresLVA3174BLK2026-07-21
00810226441248SuresLVA3174RPF2026-07-21
00810178889334SuresLVA2040NAV2026-07-17
00810178889341SuresLVA2040NAV2PAK2026-07-17
00810178889358SuresLVA2040NAV4PAK2026-07-17
00810226441156SuresLVA2040BLK2026-07-17
00810226441163SuresLVA2040BLK2PAK2026-07-17
00810226441170SuresLVA2040BLK4PAK2026-07-17
00810226441187SuresLVA2040TAN2026-07-17
00810226441194SuresLVA2040TAN2PAK2026-07-17
00810226441200SuresLVA2040TAN4PAK2026-07-17
00810226440593CoreTechSUP31702026-07-16
00818323020014ViveLVA10412026-07-16
00810226440623ViveSUP3168BGES2026-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810226440593CoreTechVIVE HEALTH LLCITW2026-07-16
00049696508384THERA PlusFOURSTAR GROUP INC.ITW2026-06-09
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
00810113579429CoreTechVIVE HEALTH LLCITW2024-10-24