FDA.reportPublic FDA data

BMI

Primary DI
G088KNEL0
Brand
BMI
Company
Blake Manufacturing, Inc.
Model
KNE-L
Catalog number
KNE-L
Device description
Knee, Neoprene Orthosis, size Large
Published
2021-12-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
ITQJoint, Knee, External Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITQJoint, Knee, External BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G088KNEL0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Knee orthosisAn externally applied orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the knee; it may incorporate hinges for improved support. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
103449711
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G088KCALL0BMIKCA-LLKCA-LL2022-09-21
G088KCALR0BMIKCA-LRKCA-LR2022-09-21
G088KCAML0BMIKCA-MLKCA-ML2022-09-21
G088KCAMR0BMIKCA-MRKCA-MR2022-09-21
G088KCAPL0BMIKCA-PLKCA-PL2022-09-21
G088KCAPR0BMIKCA-PRKCA-PR2022-09-21
G088KCASL0BMIKCA-SLKCA-SL2022-09-21
G088KCASR0BMIKCA-SRKCA-SR2022-09-21
G088KCAXL0BMIKCA-XLKCA-XL2022-09-21
G088KCAXR0BMIKCA-XRKCA-XR2022-09-21
G088KCAXXL0BMIKCA-XXLKCA-XXL2022-09-21
G088KCAXXR0BMIKCA-XXRKCA-XXR2022-09-21
G088DSKCALL0PanaceaDS-KCA-LLDS-KCA-LL2022-09-20
G088DSKCALR0PanaceaDS-KCA-LRDS-KCA-LR2022-09-20
G088DSKCAML0PanaceaDS-KCA-MLDS-KCA-ML2022-09-20
G088DSKCAMR0PanaceaDS-KCA-MRDS-KCA-MR2022-09-20
G088DSKCAPL0PanaceaDS-KCA-PLDS-KCA-PL2022-09-20
G088DSKCAPR0PanaceaDS-KCA-PRDS-KCA-PR2022-09-20
G088DSKCASL0PanaceaDS-KCA-SLDS-KCA-SL2022-09-20
G088DSKCASR0PanaceaDS-KCA-SRDS-KCA-SR2022-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00609271610811"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (small)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610828"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (medium)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610835"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610842"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (x-large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610859"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (xx-large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610866"Knee Immobilizer, Super-Lite, Contoured Stay, 20"" (small)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610873"Knee Immobilizer, Super-Lite, Contoured Stay, 20"" (x-large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610880"Knee Immobilizer, Super-Lite, Contoured Stay, 20"" (xx-large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610897"Knee Immobilizer, Super-Lite, Contoured Stay, 24"" (small)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610903"Knee Immobilizer, Super-Lite, Contoured Stay, 24"" (medium)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610910"Knee Immobilizer, Super-Lite, Contoured Stay, 24"" (large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610927"Knee Immobilizer, Super-Lite, Contoured Stay, 24"" (x-large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08