FDA.report

MEDI

Primary DI
00636257131350
Brand
MEDI
Company
MEDI MANUFACTURING, INC.
Model
RKIT4106
Device description
M4S REPLACEMENT PAD&STRAP SET XXL RT
Published
2019-01-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
ITQJOINT, KNEE, EXTERNAL BRACE

Product Code Classifications

CodeDeviceSpecialtyClass
ITQJoint, Knee, External BracePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00636257131350PrimaryGS10

GMDN Terms

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. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-6334info@mediusa.com

Regulatory Flags

DUNS number
960754430
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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 DIBrandModelCatalogPublished
00636257211281MEDIKCOR2CM12026-03-17
00636257211298MEDIKCOR2CM22026-03-17
00636257211304MEDIKCOR2CM32026-03-17
00636257211311MEDIKCOR2CM42026-03-17
00636257211328MEDIKCOR2LT12026-03-17
00636257211335MEDIKCOR2LT22026-03-17
00636257211342MEDIKCOR2LT32026-03-17
00636257211359MEDIKCOR2LT42026-03-17
00636257211366MEDIKCOR2MC12026-03-17
00636257211373MEDIKCOR2MC22026-03-17
00636257211380MEDIKCOR2MC32026-03-17
00636257211397MEDIKCOR2MC42026-03-17
00636257211403MEDIKBST2DR12026-03-17
00636257211410MEDIKBST2DR22026-03-17
00636257211427MEDIKBST2DR32026-03-17
00636257211434MEDIKBST2DR42026-03-17
00636257211441MEDIKBST2FG12026-03-17
00636257211458MEDIKBST2FG22026-03-17
00636257211465MEDIKBST2FG32026-03-17
00636257211472MEDIKBST2FG42026-03-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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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