FDA.reportPublic FDA data

Universal Foam Knee Immobilizer

Primary DI
00802357236756
Brand
Universal Foam Knee Immobilizer
Company
MEDICAL SPECIALTIES INCORPORATED
Model
223675
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00802357236756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00802357236756008023572367568023572367560802357236756

GMDN Terms#

Term, Definition table
TermDefinition
Knee immobilizerA rigid support used to temporarily render the knee immovable, either preoperatively or following injury or arthroscopy. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
003173028
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00802357230846Tee Pee Thumb Protector2230842022-12-08
00802357236411ASO Speed Lacer II Ankle Stabilizer w/Stays2236412025-05-06
00802357236428ASO Speed Lacer II Ankle Stabilizer w/Stays2236422025-05-06
00802357236442ASO Speed Lacer II Ankle Stabilizer w/Stays2236442025-05-06
00802357236459ASO Speed Lacer II Ankle Stabilizer w/Stays2236452025-05-06
00802357236466ASO Speed Lacer II Ankle Stabilizer w/Stays2236462025-05-06
00802357236473ASO Speed Lacer II Ankle Stabilizer w/Stays2236472025-05-06
00802357172313Gripper 3 Knee, 12" CoolFlex1172312025-01-14
00802357172320Gripper 3 Knee, 12" CoolFlex1172322025-01-14
00802357172344Gripper 3 Knee, 12" Coolflex1172342025-01-14
00802357172351Gripper 3 Knee, 12" Coolflex1172352025-01-14
00802357172368Gripper 3 Knee, 12" Coolflex1172362025-01-14
00802357172375Gripper 3 Knee, 12" Coolflex1172372025-01-14
00802357172382Gripper 3 Knee, 12" Coolflex1172382025-01-14
00802357172399Gripper 3 Knee, 12" Coolflex1172392025-01-14
00802357234400EPIGEL W/STAYS, UNIVERSAL2234402025-01-14
00802357240012TRIPOD WRIST LACER II2240012025-01-14
00802357240029TRIPOD WRIST LACER II2240022025-01-14
00802357240043TRIPOD WRIST LACER II2240042025-01-14
00802357240050TRIPOD WRIST LACER II2240052025-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810113579665ViveVIVE HEALTH LLCITQ2026-02-09
00810113579672ViveVIVE HEALTH LLCITQ2026-02-09
00810113579689ViveVIVE HEALTH LLCITQ2026-02-09
00810113579696ViveVIVE HEALTH LLCITQ2026-02-09
00810179882440CopperFitIdeavillage Products CorpITQ2026-01-13
16974500613576Knee BraceGCMEDICA ENTERPRISE LTD.(WUXI)ITQ2025-12-12
16974500613583Knee braceGCMEDICA ENTERPRISE LTD.(WUXI)ITQ2025-12-12
00810113683065ManaEZ ROM Ice ShortManamed, Inc.ITQ2025-10-17
00810113683522ManaEZ ROM Ice CureTechManamed, Inc.ITQ2025-10-03
00636257207727MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
00636257207734MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
00636257207741MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
00636257207758MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
00636257207765MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
00636257207772MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
00636257207789MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
06971503604528comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.ITQ2025-08-28
00190446660453PROCAREDJO, LLCITQ2025-07-23
00749756395489DeRoyalDEROYAL INDUSTRIES, INC.ITQ2025-07-23
00819567017891ComfytopiaComfytopia, Inc.ITQ2025-07-09
00819567017907ComfytopiaComfytopia, Inc.ITQ2025-07-09
00854194003138ComfytopiaComfytopia, Inc.ITQ2025-07-09
10810113579891ViveVIVE HEALTH LLCITQ2025-07-08
10810113579907ViveVIVE HEALTH LLCITQ2025-07-08
10810113579914ViveVIVE HEALTH LLCITQ2025-07-08
10810113579921ViveVIVE HEALTH LLCITQ2025-07-08
00810113579931ViveVIVE HEALTH LLCITQ2025-07-08
10810113579945ViveVIVE HEALTH LLCITQ2025-07-08
10810113579952ViveVIVE HEALTH LLCITQ2025-07-08
00190446660545PROCAREDJO, LLCITQ2025-07-07