FDA.reportPublic FDA data

CoreTech

Primary DI
00810178885404
Brand
CoreTech
Company
VIVE HEALTH LLC
Model
SUP3120BLKLS
Device description
Anterior Carbon Fiber AFO (Left) Small
Published
2026-05-05
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
00810178885404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810178885404008101788854048101788854040810178885404

GMDN Terms#

Term, Definition table
TermDefinition
Ankle/foot orthosisA prefabricated (non-customized) externally applied and wearable appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct orthopaedic deformities/injuries or to improve function of the ankle and/or foot through actions such as alignment, hinge-support, or dorsiflexion assistance. It may also be intended to offload and redistribute foot pressures that affect pedal circulation to improve blood flow and help heal diabetic foot ulcers or postsurgical wounds, and may include patient adaptable plantar inserts. This is a reusable device.

Regulatory Flags#

DUNS number
047025993
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810041982483ViveLVA2057BLU2026-05-14
00818323022797ViveLVA1003PAK2 2026-05-11
00818323025279ViveLVA10032026-05-11
00810113576817ViveLVA3049BLKML6M72024-07-17
00810113576824ViveLVA3049BLKCM92024-07-17
00810113576831ViveLVA3049BLKBM62024-07-17
00810113579627ViveLVA3078WHTS2025-04-04
00810113579634ViveLVA3078WHTM2025-04-04
00810113579641ViveLVA3078WHTL2025-04-04
00810113579658ViveLVA3078WHTL2025-04-04
00810178883516ViveLVA3099BLK2025-07-17
00818323025002VIVELVA1099BLK2019-03-24
00818323025019VIVELVA1099GRY2019-03-24
00818323025026VIVELVA1099PUR2019-03-24
00810178883639ViveLVA3102BLK2025-08-07
00810178883301ViveLVA3098BLK2025-07-17
00810178883523ViveLVA3100BLK2025-07-17
00810178883530ViveLVA3100PUR2025-07-17
00810178881857ViveLVA3086BLUS2025-07-15
00810178881864ViveLVA3086BLUM2025-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178885398CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885411CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885428CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885435CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885442CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885459CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885466CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885473CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885480CoreTechVIVE HEALTH LLCITW2026-05-05
00810178886135ViveVIVE HEALTH LLCITW2026-05-05
00810178886142ViveVIVE HEALTH LLCITW2026-05-05
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
00810113683898FlexSafe Ankle Recovery Orthosis, LargeManamed, Inc.ITW2025-10-31
00810113683904FlexSafe Ankle Recovery Orthosis, MediumManamed, Inc.ITW2025-10-31
00810113683911FlexSafe Ankle Recovery Orthosis, SmallManamed, Inc.ITW2025-10-31
00810113683928FlexSafe Ankle Recovery Orthosis, Extra LargeManamed, Inc.ITW2025-10-31
00810113683935FlexSafe Ankle Recovery Orthosis, Extra Small Manamed, Inc.ITW2025-10-31
00810113579801ViveVIVE HEALTH LLCITW2025-05-20
00810113579818ViveVIVE HEALTH LLCITW2025-05-20
00810113579825ViveVIVE HEALTH LLCITW2025-05-20
00810113579832ViveVIVE HEALTH LLCITW2025-05-20
00810113579849ViveVIVE HEALTH LLCITW2025-05-20
00810113579429CoreTechVIVE HEALTH LLCITW2024-10-24
00810113579436CoreTechVIVE HEALTH LLCITW2024-10-24
00810113579443CoreTechVIVE HEALTH LLCITW2024-10-24