FDA.reportPublic FDA data

TRAINERS CHOICE

Primary DI
00831313000292
Brand
TRAINERS CHOICE
Company
Trainer's Choice Inc
Model
306
Device description
WRIST BRACE LFT L/XL
Published
2025-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
00831313000292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00831313000292008313130002928313130002920831313000292

GMDN Terms#

Term, Definition table
TermDefinition
Hand/finger splint, reusableA prefabricated (non-customized) wearable rigid or semi-rigid device intended to immobilize an injured/diseased hand and/or finger to support, align or prevent injury during the healing process. It is applied externally to the hand/finger/wrist and typically held in place with self-retaining fasteners (e.g., Velcro bands) or bandage wraps. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18007069834info@trainerschoice.on.ca

Regulatory Flags#

DUNS number
250831179
Device count
1
Premarket exempt
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00831313005396TRAINERS CHOICE5012025-05-15
00831313000698TRAINERS CHOICE2052025-05-15
00831313005372TRAINERS CHOICE2072025-05-15
00831313000094TRAINERS CHOICE1022025-05-14
00831313000100TRAINERS CHOICE1022025-05-14
00831313000230TRAINERS CHOICE3062025-05-14
00831313000247TRAINERS CHOICE3062025-05-14
00831313000285TRAINERS CHOICE3062025-05-14
00831313000605TRAINERS CHOICE7102025-05-14
00831313005341TRAINERS CHOICE1162025-05-14

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