FDA.reportPublic FDA data

Formthotics

Primary DI
09419430003047
Brand
Formthotics
Company
FOOT SCIENCE INTERNATIONAL LIMITED
Model
FM01-OrSmA-Bl-LA
Device description
Formthotics Medical Original Single Medium - L
Published
2024-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
09419430003047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09419430003047094194300030479419430003047

GMDN Terms#

Term, Definition table
TermDefinition
Orthotic insole, prefabricated, antimicrobialA prefabricated orthopaedic shoe insert typically available for use by a layperson intended to provide supplemental support for the arch and/or heel of the foot, whilst inhibiting microbes such as viruses, bacteria and fungi. It is typically made of fabric and/or synthetic polymer materials (e.g., wool, viscose, silicone gel, foam) impregnated with an antimicrobial substance, which is designed to resist extreme load and may provide thermal insulation. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
590255113
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09419430015361FormthoticsFM01-LpDmB-Bg-2S2025-07-17
09419430015378FormthoticsFM01-LpDmB-Bg-XS2025-07-17
09419430015385FormthoticsFM01-LpDmB-Bg-SM2025-07-17
09419430015392FormthoticsFM01-LpDmB-Bg-ME2025-07-17
09419430015408FormthoticsFM01-LpDmB-Bg-LA2025-07-17
09419430015415FormthoticsFM01-LpDmB-Bg-XL2025-07-17
09419430015422FormthoticsFM01-LpDmA-Bg-2L2025-07-17
09419430015446FormthoticsFM01-SfDmBpBg-XS2025-07-17
09419430015453FormthoticsFM01-SfDmBpBg-SM2025-07-17
09419430015460FormthoticsFM01-SfDmBpBg-ME2025-07-17
09419430015477FormthoticsFM01-SfDmBpBg-LA2025-07-17
09419430015484FormthoticsFM01-SfDmBpBg-XL2025-07-17
09419430015491FormthoticsFM01-SfDmApBg-2L2025-07-17
09419430015514FormthoticsFM01-WfDmA-Bg-2S2025-07-17
09419430015521FormthoticsFM01-WfDmA-Bg-XS2025-07-17
09419430015538FormthoticsFM01-WfDmA-Bg-SM2025-07-17
09419430015545FormthoticsFM01-WfDmA-Bg-ME2025-07-17
09419430015552FormthoticsFM01-WfDmA-Bg-LA2025-07-17
09419430015569FormthoticsFM01-WfDmA-Bg-XL2025-07-17
09419430015576FormthoticsFM01-WfDmA-Bg-2L2025-07-17

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