FDA.reportPublic FDA data

Guardian Supporter

Primary DI
08809818038029
Brand
Guardian Supporter
Company
BM KOREA CO., LTD
Model
GKC-XL
Device description
"""This product is a device that provides support by compressing or immobilizing certain parts of the body, such as the waist, knees, or neck.Including casting tape, but excluding those that do not provide support or reinforcement."""
Published
2025-03-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MNEOrthosis, Moldable, Supportive, Skin Protective

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNEOrthosis, Moldable, Supportive, Skin ProtectivePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809818038029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809818038029088098180380298809818038029

GMDN Terms#

Term, Definition table
TermDefinition
Thoracic cage orthosis force meterAn electronic device designed to measure the force on the compression plate of a thoracic cage orthosis when worn by a patient, or to estimate thoracic elasticity prior to applying a thoracic cage orthosis. These measurements are used to facilitate decisions about the modification of custom treatment parameters. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length560Millimeter
Width430Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
557799209
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
08809255540024Galaxy Mis Screw SystemGXMS-55302017-07-11
08809255540031Galaxy Mis Screw SystemGXMS-55352017-07-14
08809255540048Galaxy Mis Screw SystemGXMS-55402017-07-14
08809255540055Galaxy Mis Screw SystemGXMS-55452017-07-14
08809255540062Galaxy Mis Screw SystemGXMS-55502017-07-14
08809255540079Galaxy Mis Screw SystemGXMS-55552017-07-14
08809255540086Galaxy Mis Screw SystemGXMS-55602017-07-14
08809255540093Galaxy Mis Screw SystemGXMS-65302017-07-14
08809255540109Galaxy Mis Screw SystemGXMS-65352017-07-14
08809255540116Galaxy Mis Screw SystemGXMS-65402017-07-14
08809255540123Galaxy Mis Screw SystemGXMS-65452017-07-14
08809255540130Galaxy Mis Screw SystemGXMS-65502017-07-14
08809255540147Galaxy Mis Screw SystemGXMS-65552017-07-14
08809255540154Galaxy Mis Screw SystemGXMS-65602017-07-14
08809255540161Galaxy Mis Screw SystemGXMS-75302017-07-14
08809255540178Galaxy Mis Screw SystemGXMS-75352017-07-14
08809255540185Galaxy Mis Screw SystemGXMS-75402017-07-14
08809255540192Galaxy Mis Screw SystemGXMS-75452017-07-14
08809255540208Galaxy Mis Screw SystemGXMS-75502017-07-14
08809255540215Galaxy Mis Screw SystemGB300-55352017-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809818038265Guardian SupporterBM KOREA CO., LTDMNE2025-06-23
08809818038272Guardian SupporterBM KOREA CO., LTDMNE2025-06-23
08809818038289Guardian SupporterBM KOREA CO., LTDMNE2025-06-23
08809818038296Guardian SupporterBM KOREA CO., LTDMNE2025-06-23
10185571000509Orpyx Custom Sensory Insole SystemOrpyxMNE2025-06-19
10185571000516Orpyx Custom Sensory Insole RefillOrpyxMNE2025-06-19
08809818037992Guardian SupporterBM KOREA CO., LTDMNE2025-03-20
08809818038005Guardian SupporterBM KOREA CO., LTDMNE2025-03-20
08809818038012Guardian SupporterBM KOREA CO., LTDMNE2025-03-20
08809818038074Guardian SupporterBM KOREA CO., LTDMNE2025-03-20
08809818038081Guardian SupporterBM KOREA CO., LTDMNE2025-03-20
08809818038098Guardian SupporterBM KOREA CO., LTDMNE2025-03-20
08809818038104Guardian SupporterBM KOREA CO., LTDMNE2025-03-20
10185571000332Orpyx Sensory InsolesOrpyxMNE2025-02-07
10185571000349Orpyx Sensory InsolesOrpyxMNE2025-02-07
10185571000356Orpyx Sensory InsolesOrpyxMNE2025-02-07
10185571000363Orpyx Sensory InsolesOrpyxMNE2025-02-07
10185571000417Orpyx Sensory InsolesOrpyxMNE2025-02-07
10185571000462Orpyx Sensory InsolesOrpyxMNE2025-02-07
10185571000479Orpyx Sensory InsolesOrpyxMNE2025-02-07
10185571000486Orpyx Sensory InsolesOrpyxMNE2025-02-07
10185571000493Orpyx Sensory InsolesOrpyxMNE2025-02-07
06970742221695DR -HOSGuangzhou Xinbo Electronic Co., Ltd.MNE2021-09-01
06970742221701DR -HOSGuangzhou Xinbo Electronic Co., Ltd.MNE2021-09-01
06970742221718DR -HOSGuangzhou Xinbo Electronic Co., Ltd.MNE2021-09-01
06970742221725DR -HOSGuangzhou Xinbo Electronic Co., Ltd.MNE2021-09-01
06970742221732DR -HOSGuangzhou Xinbo Electronic Co., Ltd.MNE2021-09-01
06970742221749DR -HOSGuangzhou Xinbo Electronic Co., Ltd.MNE2021-09-01
06970742221756DR -HOSGuangzhou Xinbo Electronic Co., Ltd.MNE2021-09-01
10185571000042Orpyx SIOrpyxMNE2020-04-26