FDA.reportPublic FDA data

Formthotics

Primary DI
09419430001340
Brand
Formthotics
Company
FOOT SCIENCE INTERNATIONAL LIMITED
Model
FM01-CfShB-Re-2S
Device description
Formthotics Medical Comfort Single Hard - XXS
Published
2024-02-02
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
09419430001340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09419430001340094194300013409419430001340

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
00636257215913MEDIMEDI MANUFACTURING, INC.IQI2026-08-21
00636257215920MEDIMEDI MANUFACTURING, INC.IQI2026-08-21
00636257215937MEDIMEDI MANUFACTURING, INC.IQI2026-08-21
00636257215944MEDIMEDI MANUFACTURING, INC.IQI2026-08-21
00636257215951MEDIMEDI MANUFACTURING, INC.IQI2026-08-21
00636257215968MEDIMEDI MANUFACTURING, INC.IQI2026-08-21
00190446660590PROCAREDJO, LLCIQI2026-07-31
00190446660606PROCAREDJO, LLCIQI2026-07-31
00190446660613PROCAREDJO, LLCIQI2026-07-31
00190446660620PROCAREDJO, LLCIQI2026-07-31
00190446660637PROCAREDJO, LLCIQI2026-07-31
00190446660644PROCAREDJO, LLCIQI2026-07-31
00810178883127ViveVIVE HEALTH LLCIQI2026-07-21
00810178883134ViveVIVE HEALTH LLCIQI2026-07-21
00810178883141ViveVIVE HEALTH LLCIQI2026-07-21
00810178883158ViveVIVE HEALTH LLCIQI2026-07-21
00400000326986MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000326993MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327006MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327013MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327020MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327037MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327044MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327051MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327068MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327075MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327082MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327099MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327105MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327112MEDIMEDI MANUFACTURING, INC.IQI2026-07-20