FDA.reportPublic FDA data

CoreTech

Primary DI
00810178884759
Brand
CoreTech
Company
VIVE HEALTH LLC
Model
SUP3116R
Device description
Hip ROM Brace (Right)
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
00810178884759PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810178884759008101788847598101788847590810178884759

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
00810178889723ViveSUP3158BLKXS2026-05-27
00810178889730ViveSUP3158BLKS2026-05-27
00810178889747ViveSUP3158BLKM2026-05-27
00810178889754ViveSUP3158BLKL2026-05-27
00810178889761ViveSUP3158BLKXL2026-05-27
00810178889778ViveSUP3159BLKXS2026-05-27
00810178889785ViveSUP3159BLKS2026-05-27
00810178889792ViveSUP3159BLKM2026-05-27
00810178889808ViveSUP3159BLKL2026-05-27
00810178889815ViveSUP3159BLKXL2026-05-27
00810178889822ViveSUP3160BLKXS2026-05-27
00810178889839ViveSUP3160BLKS2026-05-27
00810178889846ViveSUP3160BLKM2026-05-27
00810178889853ViveSUP3160BLKL2026-05-27
00810178889860ViveSUP3160BLKXL2026-05-27
00810178889877ViveSUP3161BLKXS2026-05-27
00810178889884ViveSUP3161BLKS2026-05-27
00810178889891ViveSUP3161BLKM2026-05-27
00810178889907ViveSUP3161BLKL2026-05-27
00810178889914ViveSUP3161BLKXL2026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178884742CoreTechVIVE 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