FDA.reportPublic FDA data

Elite Orthopaedics

Primary DI
00816591013851
Brand
Elite Orthopaedics
Company
Elite Orthopaedics, Inc.
Model
T98722
Catalog number
T98722
Device description
Pro Select Full Shell Walker, Low, Small
Published
2023-08-04
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
ITWJoint, Ankle, External Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITWJoint, Ankle, External BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816591013851PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816591013851008165910138518165910138510816591013851

GMDN Terms#

Term, Definition table
TermDefinition
Ankle/foot orthosisA prefabricated (non-customized) externally applied and wearable 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 patient adaptable plantar inserts. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
803168228
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816591010690Elite Orthopaedics30061-R30061-R2023-08-17
00816591010706Elite Orthopaedics30061-L30061-L2023-08-17
00816591010713Elite Orthopaedics30062-R30062-R2023-08-17
00816591010720Elite Orthopaedics30062-L30062-L2023-08-17
00816591010737Elite Orthopaedics30063-R30063-R2023-08-17
00816591010744Elite Orthopaedics30063-L30063-L2023-08-17
00816591010751Elite Orthopaedics30064-R30064-R2023-08-17
00816591010768Elite Orthopaedics30064-L30064-L2023-08-17
00816591010775Elite Orthopaedics30065-R30065-R2023-08-17
00816591010782Elite Orthopaedics30065-L30065-L2023-08-17
00816591010799Elite Orthopaedics31061-R31061-R2023-08-18
00816591010805Elite Orthopaedics31062-R31062-R2023-08-18
00816591010812Elite Orthopaedics31063-R31063-R2023-08-18
00816591010829Elite Orthopaedics31064-R31064-R2023-08-18
00816591010836Elite Orthopaedics31065-R31065-R2023-08-18
00816591010843Elite Orthopaedics31061-L31061-L2023-08-18
00816591010850Elite Orthopaedics31062-L31062-L2023-08-18
00816591010867Elite Orthopaedics31063-L31063-L2023-08-18
00816591010874Elite Orthopaedics31064-L31064-L2023-08-18
00816591010881Elite Orthopaedics31065-L31065-L2023-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178889723ViveVIVE HEALTH LLCITW2026-05-27
00810178889730ViveVIVE HEALTH LLCITW2026-05-27
00810178889747ViveVIVE HEALTH LLCITW2026-05-27
00810178889754ViveVIVE HEALTH LLCITW2026-05-27
00810178889761ViveVIVE HEALTH LLCITW2026-05-27
00810178889778ViveVIVE HEALTH LLCITW2026-05-27
00810178889785ViveVIVE HEALTH LLCITW2026-05-27
00810178889792ViveVIVE HEALTH LLCITW2026-05-27
00810178889808ViveVIVE HEALTH LLCITW2026-05-27
00810178889815ViveVIVE HEALTH LLCITW2026-05-27
00810178889822ViveVIVE HEALTH LLCITW2026-05-27
00810178889839ViveVIVE HEALTH LLCITW2026-05-27
00810178889846ViveVIVE HEALTH LLCITW2026-05-27
00810178889853ViveVIVE HEALTH LLCITW2026-05-27
00810178889860ViveVIVE HEALTH LLCITW2026-05-27
00810178889877ViveVIVE HEALTH LLCITW2026-05-27
00810178889884ViveVIVE HEALTH LLCITW2026-05-27
00810178889891ViveVIVE HEALTH LLCITW2026-05-27
00810178889907ViveVIVE HEALTH LLCITW2026-05-27
00810178889914ViveVIVE HEALTH LLCITW2026-05-27
00749756880169DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756880183DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756888127DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756888134DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756888141DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756888158DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00810113579801ViveVIVE HEALTH LLCITW2025-05-20
00810113579818ViveVIVE HEALTH LLCITW2025-05-20
00810113579429CoreTechVIVE HEALTH LLCITW2024-10-24
00810113579436CoreTechVIVE HEALTH LLCITW2024-10-24