FDA.reportPublic FDA data

Turtlebrace

Primary DI
20628634832046
Brand
Turtlebrace
Company
9321-8758 Québec Inc
Model
Ankle Pediatric Reinforced
Catalog number
TBCPR-02, TBCPR-03
Device description
The brace is composed of a low-temperature thermoplastic fused between layers of 3D stretchable knitted fabric. The brace can be molded directly to the patient to immobilize an ankle, with the ability to be remolded to follow the patient's change in morphology (loss of swelling), evolution in a treatment (tendon stretching for toe walkers), correction of deformities, or other reason in accordance with the treatment procedure for a specific patient. This is a multiple use single patient brace.Size small (01), medium (02), or large (03), Pediatric (PED)
Published
2023-01-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
20628634832046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2062863483204620628634832046

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made lower-limb orthosisAn externally-applied wearable appliance constructed with specific characteristics (e.g., size, shape, material), as prescribed by a healthcare provider for a specified patient (custom-made), intended to support and correct deformities of the leg and/or feet. It may be one of numerous different designs and is typically made of synthetic and textile materials. This is a single-patient reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
(819) 473-0657info@turtlebrace.com

Regulatory Flags#

DUNS number
203875315
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10628634832018TurtlebraceAnkle Baby TBBC-01, TBBC-02, TBBC-032023-01-16
10628634832162TurtlebraceElbow Baby TBBCo-01, TBBCo-02, TBBCo-03, TBBCo-042023-01-16
20628634832039TurtlebraceAnkle PediatricTBCP-01, TBCP-02,TBCP-032023-01-16
20628634832077TurtlebraceWrist Pediatric with zipper closureTBPPZ-02,TBPPZ-032023-01-16
20628634832084TurtlebraceWrist Pediatric with velcro closureTBPPV-02,TBPPV-032023-01-16
20628634832145TurtlebraceWrist Pediatric HBPP-02,HBPP-032023-01-16
20628634832176TurtlebraceElbow Pediatric TBCoP-01, TBCoP-02, TBCoP-03, TBCoP-042023-01-16
30628634832050TurtlebraceAnkle AdultTBCA-01, TBCA-02, TBCA-032023-01-16
30628634832067TurtlebraceAnkle Adult ReinforcedTBCAR-01, TBCAR-02, TBCAR-032023-01-16
30628634832098TurtlebraceWrist Adult with zipper closureTBPAZ-01, TBPAZ-02,TBPAZ-032023-01-16
30628634832104TurtlebraceWrist Adult with velcro closureTBPAV-01, TBPAV-02,TBPAV-032023-01-16
30628634832159TurtlebraceWrist AdultHBPA-01, HBPA-02,HBPA-032023-01-16
30628634832180TurtlebraceElbow AdultTBCoA-01, TBCoA-02, TBCoA-032023-01-16
80628634832116TurtlebraceUniversal Fingers AttachementEDUA2023-01-16
80628634832123TurtlebraceUniversal Thumb AttachementEPUA2023-01-16
80628634832130TurtlebraceUniversal FingerDUA2023-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00636257221631MEDIMEDI MANUFACTURING, INC.IQI2026-07-20