FDA.reportPublic FDA data

Elite Orthopaedics

Primary DI
00816591013295
Brand
Elite Orthopaedics
Company
Elite Orthopaedics, Inc.
Model
T98522
Catalog number
T98522
Device description
FSX Air Walker, Low Top, 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
00816591013295PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816591013295008165910132958165910132950816591013295

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
16974500613446Ankle SupportGCMEDICA ENTERPRISE LTD.(WUXI)ITW2025-12-08
00810113682891ManaEZ Ankle 06 Extra SmallManamed, Inc.ITW2025-09-26
00810113682907ManaEZ Ankle 06 SmallManamed, Inc.ITW2025-09-26
00810113682914ManaEZ Ankle 06 MediumManamed, Inc.ITW2025-09-26
00810113682921ManaEZ Ankle 06 LargeManamed, Inc.ITW2025-09-26
00810113682938ManaEZ Ankle 06 Extra LargeManamed, Inc.ITW2025-09-26
00810113682945ManaEZ Ankle 06 Extra Extra LargeManamed, Inc.ITW2025-09-26
00810113683126ManaEZ Night Splint, Plantar Fasciitis, SmallManamed, Inc.ITW2025-09-26
00810113683133ManaEZ Night Splint, Plantar Fasciitis, MediumManamed, Inc.ITW2025-09-26
00810113683140ManaEZ Night Splint, Plantar Fasciitis, LargeManamed, Inc.ITW2025-09-26
00810113683324ManaGO71 Ankle Brace Extra LargeManamed, Inc.ITW2025-09-26
00810113683331ManaGO71 Ankle Brace LargeManamed, Inc.ITW2025-09-26
00810113683348ManaGO71 Ankle Brace MediumManamed, Inc.ITW2025-09-26
00810113683355ManaGO71 Ankle Brace SmallManamed, Inc.ITW2025-09-26
00749756399333DeRoyalDEROYAL INDUSTRIES, INC.ITW2025-07-30
00749756399340DeRoyalDEROYAL INDUSTRIES, INC.ITW2025-07-30
00749756399357DeRoyalDEROYAL INDUSTRIES, INC.ITW2025-07-30
00749756399364DeRoyalDEROYAL INDUSTRIES, INC.ITW2025-07-30
00749756399371DeRoyalDEROYAL INDUSTRIES, INC.ITW2025-07-30
00190446662563PROCAREDJO, LLCITW2025-07-10
00190446662570PROCAREDJO, LLCITW2025-07-10
00190446662587PROCAREDJO, LLCITW2025-07-10
00190446662594PROCAREDJO, LLCITW2025-07-10
00190446662600PROCAREDJO, LLCITW2025-07-10
00819567011660ComfytopiaComfytopia, Inc.ITW2025-07-09
00819567017853ComfytopiaComfytopia, Inc.ITW2025-07-09
00819567017860ComfytopiaComfytopia, Inc.ITW2025-07-09
00819567017877ComfytopiaComfytopia, Inc.ITW2025-07-09
00819567017884ComfytopiaComfytopia, Inc.ITW2025-07-09
00854194003121ComfytopiaComfytopia, Inc.ITW2025-07-09