FDA.reportPublic FDA data

DONJOY PERFORMANCE

Primary DI
00190446237822
Brand
DONJOY PERFORMANCE
Company
DJO, LLC
Model
DP171AB01-BLK-M
Device description
BIONIC SPEED-WRAP ANKLE, BLACK, MEDIUM
Published
2022-05-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00190446237822PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446237822001904462378221904462378220190446237822

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
081840873
Device count
1
Premarket exempt
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190446780601CHATTANOOGA81-50102023-04-25
00190446780618CHATTANOOGA81-50112023-04-25
00190446750598CHATTANOOGA47382022-09-02
00190446750604CHATTANOOGA47822022-09-02
00190446757214CHATTANOOGA4782-12022-09-02
00190446757221CHATTANOOGA4738-12022-09-02
00888912036627PROCARE79-892002022-08-22
00888912292856CHATTANOOGA2761-102016-09-15
00888912292863CHATTANOOGA2761-22016-09-15
00888912294249CHATTANOOGA2789-102016-09-15
00888912294256CHATTANOOGA2789-22016-09-15
00888912296977CHATTANOOGA28742016-09-15
00888912297110CHATTANOOGA28762016-09-15
00888912297295CHATTANOOGA28782016-09-15
00888912335652CHATTANOOGA39-07012016-09-15
00888912335669CHATTANOOGA39-07022016-09-15
00888912267588CHATTANOOGA20252026-03-31
00888912267618CHATTANOOGA20272026-03-31
00888912267625CHATTANOOGA20282026-03-31
00888912267632CHATTANOOGA20292026-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178885398CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885404CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885411CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885428CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885435CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885442CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885459CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885466CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885473CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885480CoreTechVIVE HEALTH LLCITW2026-05-05
00810178886135ViveVIVE HEALTH LLCITW2026-05-05
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
00810113683898FlexSafe Ankle Recovery Orthosis, LargeManamed, Inc.ITW2025-10-31
00810113683904FlexSafe Ankle Recovery Orthosis, MediumManamed, Inc.ITW2025-10-31
00810113683911FlexSafe Ankle Recovery Orthosis, SmallManamed, Inc.ITW2025-10-31
00810113683928FlexSafe Ankle Recovery Orthosis, Extra LargeManamed, Inc.ITW2025-10-31
00810113683935FlexSafe Ankle Recovery Orthosis, Extra Small Manamed, Inc.ITW2025-10-31
00810113579801ViveVIVE HEALTH LLCITW2025-05-20
00810113579818ViveVIVE HEALTH LLCITW2025-05-20
00810113579825ViveVIVE HEALTH LLCITW2025-05-20
00810113579832ViveVIVE HEALTH LLCITW2025-05-20
00810113579849ViveVIVE HEALTH LLCITW2025-05-20
00810113579429CoreTechVIVE HEALTH LLCITW2024-10-24
00810113579436CoreTechVIVE HEALTH LLCITW2024-10-24
00810113579443CoreTechVIVE HEALTH LLCITW2024-10-24