FDA.reportPublic FDA data

QuanFoam Hip Support

Primary DI
08809642990159
Brand
QuanFoam Hip Support
Company
Tannus Co.,Ltd.
Model
QFW-VI-105
Published
2024-02-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08809642990159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809642990159088096429901598809642990159

GMDN Terms#

Term, Definition table
TermDefinition
Shock-transfering hip protectorA mechanical guard worn externally over the bony prominence of the hip (greater trochanter) intended to protect against hip (neck of femur) or femoral shaft fractures by transferring the force of a patient?s fall to the soft tissues of the thigh. It is designed in the form of a shell-like pad, typically with heat-transferring vents, made of firm materials (e.g., plastic). The device is typically held in place by modified underpants or by specialized side pockets on hip protection trousers. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
694660348
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809642990272QuanFoam Hip SupportQFM-BL-1152024-08-08
08809642990289QuanFoam Hip SupportQFM-BL-1202024-08-08
08809642990296QuanFoam Hip SupportQFM-NA-1152024-08-08
08809642990302QuanFoam Hip SupportQFM-NA-1202024-08-08
08809642990319QuanFoam Hip SupportQFW-BE-1102024-08-08
08809642990326QuanFoam Hip SupportQFW-BE-1152024-08-08
08809642990333QuanFoam Hip SupportQFW-VI-1102024-08-08
08809642990340QuanFoam Hip SupportQFW-VI-1152024-08-08
08809642990357QuanFoam Hip SupportQFW-PI-1102024-08-08
08809642990364QuanFoam Hip SupportQFW-PI-1152024-08-08
08809642990005QuanFoam Hip SupportQFM-BL-952024-02-01
08809642990012QuanFoam Hip SupportQFM-BL-1002024-02-01
08809642990029QuanFoam Hip SupportQFM-BL-1052024-02-01
08809642990036QuanFoam Hip SupportQFM-BL-1102024-02-01
08809642990043QuanFoam Hip SupportQFM-NA-952024-02-01
08809642990050QuanFoam Hip SupportQFM-NA-1002024-02-01
08809642990067QuanFoam Hip SupportQFM-NA-1052024-02-01
08809642990074QuanFoam Hip SupportQFM-NA-1102024-02-01
08809642990081QuanFoam Hip SupportQFW-BE-902024-02-01
08809642990098QuanFoam Hip SupportQFW-BE-952024-02-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178884742CoreTechVIVE HEALTH LLCITS2026-04-27
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