FDA.report

QuanFoam Hip Support

Primary DI
08809642990289
Brand
QuanFoam Hip Support
Company
Tannus Co.,Ltd.
Model
QFM-BL-120
Published
2024-08-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
ITSJoint, Hip, External Brace

Product Code Classifications

CodeDeviceSpecialtyClass
ITSJoint, Hip, External BracePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809642990289PrimaryGS10

GMDN Terms

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

Regulatory Flags

DUNS number
694660348
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08809642990272QuanFoam Hip SupportQFM-BL-1152024-08-08
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
08809642990104QuanFoam Hip SupportQFW-BE-1002024-02-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
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
08809642990166QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-02-01
08809642990173QuanFoam Hip SupportTannus Co.,Ltd.ITS2024-02-01