FDA.reportPublic FDA data

Guardian Supporter

Primary DI
08809818038296
Brand
Guardian Supporter
Company
BM KOREA CO., LTD
Model
GWT-M
Device description
This product is a device designed to provide support by compressing and immobilizing certain parts of the body (such as the waist, knees, wrists, or back); products that do not offer support or stabilization are excluded.
Published
2025-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
08809818038296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809818038296088098180382968809818038296

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
Length210Millimeter
Width210Millimeter

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
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
08809818038029Guardian 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