FDA.reportPublic FDA data

MEDI

Primary DI
00636257040379
Brand
MEDI
Company
MEDI MANUFACTURING, INC.
Model
FS10235
Device description
FOOT SOLUTIONS COMFORT PRO 35
Published
2022-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IQIORTHOSIS, LIMB BRACE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQIOrthosis, Limb BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00636257040379PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00636257040379006362570403796362570403790636257040379

GMDN Terms#

Term, Definition table
TermDefinition
Orthotic insole, prefabricated, non-antimicrobialA prefabricated shoe insert typically available for use by a layperson intended to provide supplemental support for the arch and/or heel of the foot; it does not include an antimicrobial agent(s). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-6334info@mediusa.com

Regulatory Flags#

DUNS number
960754430
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00636257213469MEDIDB1812026-05-07
00636257213551MEDISP171N12026-05-07
00636257213568MEDISP171N22026-05-07
00636257213575MEDISP171N32026-05-07
00636257213582MEDISP171N42026-05-07
00636257213599MEDISP171N52026-05-07
00636257213605MEDISP172N12026-05-07
00636257213612MEDISP172N22026-05-07
00636257213629MEDISP172N32026-05-07
00636257213636MEDISP172N42026-05-07
00636257213643MEDISP172N52026-05-07
00636257213650MEDISM171N12026-05-07
00636257213667MEDISM171N22026-05-07
00636257213674MEDISM171N32026-05-07
00636257213681MEDISM171N42026-05-07
00636257213698MEDISM171N52026-05-07
00636257213704MEDISM172N12026-05-07
00636257213711MEDISM172N22026-05-07
00636257213728MEDISM172N32026-05-07
00636257213735MEDISM172N42026-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00636257213322MEDIMEDI MANUFACTURING, INC.IQI2026-04-24
00636257213339MEDIMEDI MANUFACTURING, INC.IQI2026-04-24
00636257213346MEDIMEDI MANUFACTURING, INC.IQI2026-04-24
00636257213353MEDIMEDI MANUFACTURING, INC.IQI2026-04-24
00636257213360MEDIMEDI MANUFACTURING, INC.IQI2026-04-24
00636257213377MEDIMEDI MANUFACTURING, INC.IQI2026-04-24
00636257213384MEDIMEDI MANUFACTURING, INC.IQI2026-04-24
00636257213391MEDIMEDI MANUFACTURING, INC.IQI2026-04-24
00645517899312TrulifeTRULIFE LIMITEDIQI2026-04-22
00645517899329TrulifeTRULIFE LIMITEDIQI2026-04-22
00645517899336TrulifeTRULIFE LIMITEDIQI2026-04-22
00645517899343TrulifeTRULIFE LIMITEDIQI2026-04-22
00645517899398TrulifeTRULIFE LIMITEDIQI2026-04-22
00645517899404TrulifeTRULIFE LIMITEDIQI2026-04-22
00810075281620BoneFoamBONE FOAM, INC.IQI2025-08-15
10841156111298ACCUMEDTELEFLEX INCORPORATEDIQI2025-03-11
10841156111304ACCUMEDTELEFLEX INCORPORATEDIQI2025-03-11
00810079190102Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079190119Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079190126Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079190133Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079190140Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079190157Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079190164Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079190171Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079191703The Equinus BraceThrive Orthopedics LLCIQI2024-12-10
00810079191710Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079191727Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079191734Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079191741Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10