FDA.reportPublic FDA data

Pro-Fit Offloader Left

Primary DI
00859718007241
Brand
Pro-Fit Offloader Left
Company
Emsi
Model
FLEOLK0001 – Offloader left
Published
2023-03-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00859718007241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859718007241008597180072418597180072410859718007241

GMDN Terms#

Term, Definition table
TermDefinition
Knee support orthosisA stand-alone prefabricated (non-customized) externally applied and wearable 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. It is not a component of a larger device assembly. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
932471881
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859718007296Hypoallergenic Electrode 2x2 4pkBF50502025-12-16
00085971800729Hypoallergenic Electrode 2x2 4pkBF50502024-08-18
00858688006261TENS 3000EMS-DT30022016-09-24
00858688006285TENS 8000EMS-DT7202B2016-09-08
00858688006704TMR-ELTH-8500A85002016-10-14
00858688006964Electrode 45 x 45 16 PKELEC0019B2023-09-20
00858688006971Electrode 1.75 x 1.75 4 pack ELEC0008B2023-09-20
00859718007074Electrode 1.75 x 1.75 - 24 PKELEC0028B2023-09-20
00859718007081Electrode 4.0 x 7.0- DispersiveELEC407001B2023-09-20
00859718007098Electrode 1 Inch Round 4 PKSRELEC0001B2023-09-20
00859718007104"Electrode 2"" round 4pk"SRELEC0002B2023-09-20
00859718007111Electrode 3 Inch Round 4PKSRELEC0003B2023-09-20
00859718007135Electrode 2 x 4 Inch Rectangle SRELEC0005B2023-09-20
00859718007142Electrode 2 x 2 inch Square 4PKSRELC0015B2023-09-20
00859718007159Electrode 1.75 Inch SquareSRELEC0016B2023-09-20
00859718007289Flex-MI with ElectrodesFLEMC00012023-09-20
00859718007272Flex-MIFLEMC00012023-09-19
00858688006001Flex-TENSFLET00012016-09-02
00858688006018Flex-ITFLEI00012016-09-02
00858688006025Flex-MT PlusFLEMP00012016-09-02

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