FDA.reportPublic FDA data

DONJOY PERFORMANCE

Primary DI
00888912162548
Brand
DONJOY PERFORMANCE
Company
DJO, LLC
Model
DP151AB05-BLK-XS-L
Device description
POD ANKLE, Black, X-Small, Left
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
IQIORTHOSIS, LIMB BRACE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQIOrthosis, Limb BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888912162548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888912162548008889121625488889121625480888912162548

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190446979128AIRCAST31M-9002026-08-03
00190446898610CMFMFUSE012026-07-31
00190446660590PROCARE155-79-871132026-07-31
00190446660606PROCARE155-79-871142026-07-31
00190446660613PROCARE155-79-871172026-07-31
00190446660620PROCARE155-79-871182026-07-31
00190446660637PROCARE155-79-870502026-07-31
00190446660644PROCARE155-79-870602026-07-31
00190446922490CMFMANAGEL012026-07-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00636257220733MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220740MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220757MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220764MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220771MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220788MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220795MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220801MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220887MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220894MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220900MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220917MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220924MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220931MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220948MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220955MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220962MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220979MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220986MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220993MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257221006MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257221068MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257221075MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257221082MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00840536824288PediHipORTHOPEDIATRICS CORP.IQI2026-10-07
00840536824295PediHipORTHOPEDIATRICS CORP.IQI2026-10-07
00840536824301PediHipORTHOPEDIATRICS CORP.IQI2026-10-07
00840536824318PediHipORTHOPEDIATRICS CORP.IQI2026-10-07
00840536824325PediHipORTHOPEDIATRICS CORP.IQI2026-10-07
00840536824332PediHipORTHOPEDIATRICS CORP.IQI2026-10-07