FDA.reportPublic FDA data

CoreTech

Primary DI
00810178884742
Brand
CoreTech
Company
VIVE HEALTH LLC
Model
SUP3116L
Device description
Hip ROM Brace (Left)
Published
2026-04-27
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
ITSJoint, Hip, External Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITSJoint, Hip, External BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810178884742PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810178884742008101788847428101788847420810178884742

GMDN Terms#

Term, Definition table
TermDefinition
Hip orthosisA prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or improve function of the hip; it is not dedicated to infants. It is typically adjustable and comprised of components that include a hip/pelvic girdle, thigh cuff, and articulated hip portion. 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
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
00810226440630ViveSUP3168BGEM2026-07-14
00810226440647ViveSUP3168BGEL2026-07-14
00810226440654ViveSUP3168BGEXL2026-07-14
00810226440661ViveSUP3168BGE2XL2026-07-14
00810226440678ViveSUP3168BLKS2026-07-14
00810226440685ViveSUP3168BLKM2026-07-14
00810226440692ViveSUP3168BLKL2026-07-14
00810226440708ViveSUP3168BLKXL2026-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178884759CoreTechVIVE HEALTH LLCITS2026-04-27
00810113683515ManaEZ Hip Ice CureTechManamed, Inc.ITS2025-10-03
00810060887394Rhino MD ORTHOPAEDICS, INC.ITS2024-10-29
00810060887400Rhino MD ORTHOPAEDICS, INC.ITS2024-10-29
08809642990272QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-08-08
08809642990289QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-08-08
08809642990296QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-08-08
08809642990302QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-08-08
08809642990319QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-08-08
08809642990326QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-08-08
08809642990333QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-08-08
08809642990340QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-08-08
08809642990357QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-08-08
08809642990364QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-08-08
08809642990005QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-02-01
08809642990012QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-02-01
08809642990029QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-02-01
08809642990036QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-02-01
08809642990043QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-02-01
08809642990050QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-02-01
08809642990067QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-02-01
08809642990074QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-02-01
08809642990081QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-02-01
08809642990098QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-02-01
08809642990104QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-02-01
08809642990111QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-02-01
08809642990128QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-02-01
08809642990135QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-02-01
08809642990142QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-02-01
08809642990159QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-02-01