FDA.reportPublic FDA data

DR -HOS

Primary DI
06970742221749
Brand
DR -HOS
Company
Guangzhou Xinbo Electronic Co., Ltd.
Model
NN-AN-Blue
Device description
An ankle support. Made of cloth, the device is worn on the body
Published
2021-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
06970742221749PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970742221749069707422217496970742221749

GMDN Terms#

Term, Definition table
TermDefinition
Ankle/foot orthosisAn externally-applied appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct orthopaedic deformities/injuries or to improve function of the ankle and/or foot through actions such as alignment, hinge-support, or dorsiflexion assistance. It may also be intended to offload and redistribute foot pressures that affect pedal circulation to improve blood flow and help heal diabetic foot ulcers or postsurgical wounds, and may include customizable plantar inserts. This is a single-patient device that can be reapplied to the patient during the treatment period (reusable) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
530683813
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
06970742220339DR-HOSMotionciser2025-06-30
06970742220278DR-HOSDHP-King2023-11-12
06970742220285DR-HOSDHP-Queen2023-11-12
06970742220292DR-HOSDHP-Children2023-11-12
06970742220308DR-HOSDHP-Travel2023-11-12
06970742220315DR-HOSDHP-Leg2023-11-12
06970742221770DR -HOSDH-CP-I2022-01-07
06970742221787DR -HOSDH-P.T.S-I2022-01-07
06970742221794DR -HOSDH-P.T.S-II2022-01-07
06970742221800DR -HOSDH-P.T.S-IIA2022-01-07
06970742221817DR -HOSDH-P.T.S-IIB2022-01-07
06970742221824DR -HOSP.T.S-III2022-01-07
06970742221411DR-HO'SCP-I2020-03-01
06970742221428Equate P.T.S-II2020-03-01
06970742221435DR-HO'SP.T.S- II B2020-03-01
06970742221442DR-HO'SP.T.S-II A2020-03-01
06970742221459DR-HO'SP.T.S-II2020-03-01
06970742221732DR -HOSNN-KN-Blue2021-09-01
06970742221725DR -HOSNN-CA-Blue2021-09-01
06970742221473DR-HO'SPBR-12020-03-01

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
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
06970742221756DR -HOSGuangzhou Xinbo Electronic Co., Ltd.MNE2021-09-01
10185571000042Orpyx SIOrpyxMNE2020-04-26