TM "Rehabilitimed" TUTOR-6K XL Comfort TUTOR-6K XL Comfort

GUDID 04823097719367

It is an Orthosis for the hand bone, graphite color. Made of modern multilayer material (special velor tripled fabric (glued in a special way with polyurethane foam) with cotton terry cloth) and reinforced with a rigid wide profiled splint with an angle of 60 degrees to the hand relative to the forearm, located along the palm. Universal for the left and right hand, it can be used instead of a plaster splint.

REABILITIMED TOV

Knee support orthosis
Primary Device ID04823097719367
NIH Device Record Key8f74a713-3e61-4e0c-af8e-ce777ee4568a
Commercial Distribution StatusIn Commercial Distribution
Brand NameTM "Rehabilitimed" TUTOR-6K XL Comfort
Version Model NumberTUTOR-6K XL Comfort
Catalog NumberTUTOR-6K XL Comfort
Company DUNS364875768
Company NameREABILITIMED TOV
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone835 5030395
EmailKrut.Lora@gmail.com
Phone835 5030395
EmailKrut.Lora@gmail.com
Phone835 5030395
EmailKrut.Lora@gmail.com
Phone835 5030395
EmailKrut.Lora@gmail.com
Phone835 5030395
EmailKrut.Lora@gmail.com
Phone835 5030395
EmailKrut.Lora@gmail.com
Phone835 5030395
EmailKrut.Lora@gmail.com
Phone835 5030395
EmailKrut.Lora@gmail.com
Phone835 5030395
EmailKrut.Lora@gmail.com
Phone835 5030395
EmailKrut.Lora@gmail.com
Phone835 5030395
EmailKrut.Lora@gmail.com
Phone835 5030395
EmailKrut.Lora@gmail.com
Phone835 5030395
EmailKrut.Lora@gmail.com
Phone835 5030395
EmailKrut.Lora@gmail.com
Phone835 5030395
EmailKrut.Lora@gmail.com
Phone835 5030395
EmailKrut.Lora@gmail.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS104823097719367 [Primary]

FDA Product Code

ITMCage, Knee

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-12
Device Publish Date2025-05-04

On-Brand Devices [TM "Rehabilitimed" TUTOR-6K XL Comfort]

04823097719367It is an Orthosis for the hand bone, graphite color. Made of modern multilayer material (special
04823097722732Wrist-hand orthosis in graphite color, provides external semi-rigid dosed fixation of the carpal

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.