Thrive Orthopedics

Primary DI
00810079192724
Brand
Thrive Orthopedics
Company
Thrive Orthopedics LLC
Model
FCCIM13
Device description
Flexible Contoured Carbon Insole - 1.0 mm - US M13
Published
2026-05-27
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
00810079192724PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810079192724008100791927248100791927240810079192724

GMDN Terms#

Term, Definition table
TermDefinition
Ankle/foot orthosisA prefabricated (non-customized) externally applied and wearable appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct orthopaedic deformities/injuries or to improve function of the ankle and/or foot through actions such as alignment, hinge-support, or dorsiflexion assistance. It may also be intended to offload and redistribute foot pressures that affect pedal circulation to improve blood flow and help heal diabetic foot ulcers or postsurgical wounds, and may include patient adaptable plantar inserts. This is a reusable device.

Regulatory Flags#

DUNS number
035286635
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810079192656Thrive OrthopedicsFCCIM62026-05-27
00810079192663Thrive OrthopedicsFCCIM72026-05-27
00810079192670Thrive OrthopedicsFCCIM82026-05-27
00810079192687Thrive OrthopedicsFCCIM92026-05-27
00810079192694Thrive OrthopedicsFCCIM102026-05-27
00810079192700Thrive OrthopedicsFCCIM112026-05-27
00810079192717Thrive OrthopedicsFCCIM122026-05-27
00810079192731Thrive OrthopedicsFCCIM142026-05-27
00810079192748Thrive OrthopedicsCCIM62026-05-27
00810079192755Thrive OrthopedicsCCIM72026-05-27
00810079192762Thrive OrthopedicsCCIM82026-05-27
00810079192779Thrive OrthopedicsCCIM92026-05-27
00810079192786Thrive OrthopedicsCCIM102026-05-27
00810079192793Thrive OrthopedicsCCIM112026-05-27
00810079192809Thrive OrthopedicsCCIM122026-05-27
00810079192816Thrive OrthopedicsCCIM132026-05-27
00810079192823Thrive OrthopedicsCCIM142026-05-27
00810079192946Thrive OrthopedicsSFXSRT2026-05-27
00810079192953Thrive OrthopedicsSFSLT2026-05-27
00810079192960Thrive OrthopedicsSFSRT2026-05-27

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Primary DI, Brand, Company table
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