FDA.reportPublic FDA data

DONJOY

Primary DI
00190446286967
Brand
DONJOY
Company
DJO, LLC
Model
11-4000-0-06000
Device description
X4 KNEE BRACE, RT, UNIV, BLK
Published
2018-04-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IKKSYSTEM, ISOKINETIC TESTING AND EVALUATION
ITQJOINT, KNEE, EXTERNAL BRACE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKKSystem, Isokinetic Testing And EvaluationPhysical Medicine2
ITQJoint, Knee, External BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190446286967PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446286967001904462869671904462869670190446286967

GMDN Terms#

Term, Definition table
TermDefinition
Kinesiology ambulatory recorderA battery-powered device designed to continuously measure and record a patient's kinetic activity during routine ambulation, including monitoring the motion of individual joints/limbs, typically to assess joint mobility, gait performance, and fall-risk or frailty (e.g., during post-surgery rehabilitation). It consists of a motion sensor(s) worn on the torso or a limb (e.g., thigh, calf, wrist, ankle) while performing normal daily activities, and a computing device/software to which body movement signals are transmitted for recording/analysis; it may also be attached to or integrated in an external limb prosthesis for activity monitoring.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081840873
Device count
1
Premarket exempt
true
Serial number
true
No natural rubber latex
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
06980194220016FOURIER REHABZhuhai Rehaconn Medical Co., Ltd.IKK2026-08-14
06980194220108FOURIER REHABZhuhai Rehaconn Medical Co., Ltd.IKK2026-08-14
00810226441538ViveVIVE HEALTH LLCITQ2026-08-03
00860010525609Proprio SystemsPerry Dynamics, Inc.IKK2026-07-29
00860010525616Proprio SystemsPerry Dynamics, Inc.IKK2026-07-28
06978410840063FourierFourier Intelligence Inc.IKK2026-07-16
06978410840070FourierFourier Intelligence Inc.IKK2026-07-16
06978410840087FourierFourier Intelligence Inc.IKK2026-07-16
06975343590362Deweighting SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-07-10
06975343590379Deweighting SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-07-10
00049696508377THERA PlusFOURSTAR GROUP INC.ITQ2026-06-09
00860003483206Healing InnovationsHealing Innovations, Inc.IKK2023-09-08
00057475210434BIOS LivingThermor LtdITQ2023-03-31
0060927120013516'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120015916'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120017316'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120018016'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120019716'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120033320'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120035720'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120037120'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120038820'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120039520'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927121050920'' DLX 3-PANEL KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927121060820'' DLX 3-PANEL KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927121080620'' DLX 3-PANEL KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610774"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (small)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610781"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (medium)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610798"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610804"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (x-large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08