TM "Rehabilitimed" K-1PS M K-1PS M

GUDID 04823097706022

The orthopedic device is blue in color, has a dense structure, is a knee orthosis made of aeroprene (aeroprene is a soft, breathable, highly elastic neoprene that has additional perforations over the entire surface, which enhances air and moisture exchange.), anatomically correct shape, with an insert made of a special mesh fabric on the back of the leg. Equipped with a relief limiting silicone ring around the opening for the kneecap, reinforced with two spring stiffening ribs on the side surfaces and cross-shaped fasteners with additional straps and locks.

REABILITIMED TOV

Knee support orthosis
Primary Device ID04823097706022
NIH Device Record Key2cfe0d22-0095-4862-ad3b-4d9c39f2f52f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTM "Rehabilitimed" K-1PS M
Version Model NumberK-1PS M
Catalog NumberK-1PS M
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
GS104823097706022 [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

Devices Manufactured by REABILITIMED TOV

04823097716953 - TM "Rehabilitimed" L-4M-2 S Comfort2025-05-13 The graphite color orthopedic device for the lumbar spine, 24 cm high, is made of elastic bandage fabric and multilayer material
04823097716960 - TM "Rehabilitimed" L-4M-2 M Comfort2025-05-13 The graphite color orthopedic device for the lumbar spine, 24 cm high, is made of elastic bandage fabric and multilayer material
04823097716977 - TM "Rehabilitimed" L-4M-2 L Comfort2025-05-13 The graphite color orthopedic device for the lumbar spine, 24 cm high, is made of elastic bandage fabric and multilayer material
04823097716984 - TM "Rehabilitimed" L-4M-2 XL Comfort2025-05-13 The graphite color orthopedic device for the lumbar spine, 24 cm high, is made of elastic bandage fabric and multilayer material
04823097716991 - TM "Rehabilitimed" L-4M-2 XXL Comfort2025-05-13 The graphite color orthopedic device for the lumbar spine, 24 cm high, is made of elastic bandage fabric and multilayer material
04823097717004 - TM "Rehabilitimed" L-4M-2 XXXL Comfort2025-05-13 The graphite color orthopedic device for the lumbar spine, 24 cm high, is made of elastic bandage fabric and multilayer material
04823097717011 - TM "Rehabilitimed" L-4M-2V S Comfort2025-05-13 The graphite-colored orthopedic device for the lumbar spine, 27 cm high, is made of elastic bandage fabric and multilayer materi
04823097717028 - TM "Rehabilitimed" L-4M-2V M Comfort2025-05-13 The graphite-colored orthopedic device for the lumbar spine, 27 cm high, is made of elastic bandage fabric and multilayer materi

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