FDA.reportPublic FDA data

Formthotics

Primary DI
09419430003887
Brand
Formthotics
Company
FOOT SCIENCE INTERNATIONAL LIMITED
Model
FM01-OrDmApBt-XL
Device description
Formthotics Medical Original Dual Medium (Perf)-XL
Published
2024-01-31
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
IQIOrthosis, Limb Brace

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09419430003887PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09419430003887094194300038879419430003887

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
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
false
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
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
00840194499194Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00840194499200Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00840194499217Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00840194499224Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00840194499231Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00840194499248Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00840194499255Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00840194499262Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00840194499279Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00645517899350TrulifeTRULIFE LIMITEDIQI2026-02-17
00645517899367TrulifeTRULIFE LIMITEDIQI2026-02-17
00645517899374TrulifeTRULIFE LIMITEDIQI2026-02-17
00645517899381TrulifeTRULIFE LIMITEDIQI2026-02-17
00860014768606QuickBraceINNOMOTIVE L.L.CIQI2026-02-11
00690079011306Strassburg SockSTRASSBURG MEDICAL, LLCIQI2026-01-27
00690079011313Strassburg SockSTRASSBURG MEDICAL, LLCIQI2026-01-27
00690079012303Strassburg SockSTRASSBURG MEDICAL, LLCIQI2026-01-27
00690079012310Strassburg SockSTRASSBURG MEDICAL, LLCIQI2026-01-27
00810113682969ManaEZ Single Panel Knee Immobilizer 18"Manamed, Inc.IQI2025-11-25
00810113682976ManaEZ Single Panel Knee Immobilizer 20"Manamed, Inc.IQI2025-11-25
00810113682983ManaEZ Single Panel Knee Immobilizer 24"Manamed, Inc.IQI2025-11-25
00810113682990ManaEZ 3 Panel Knee Immobilizer 18"Manamed, Inc.IQI2025-11-25
00810113683003ManaEZ 3 Panel Knee Immobilizer 20"Manamed, Inc.IQI2025-11-25
00810113683010ManaEZ 3 Panel Knee Immobilizer 24"Manamed, Inc.IQI2025-11-25
00810113683294ManaEZ 3 Panel Knee Immobilizer 16"Manamed, Inc.IQI2025-11-25
00810079192144Thrive OrthopedicsThrive Orthopedics LLCIQI2025-11-24
00810079192151Thrive OrthopedicsThrive Orthopedics LLCIQI2025-11-24
00810079191918Thrive OrthopedicsThrive Orthopedics LLCIQI2025-11-17
00810079191925Thrive OrthopedicsThrive Orthopedics LLCIQI2025-11-17
00810079192311Thrive OrthopedicsThrive Orthopedics LLCIQI2025-11-17