TM "Rehabilitimed" K-1P L Comfort K-1P L Comfort

GUDID 04823097721612

The orthopedic device is graphite in color, the structure is dense, right, it is an elastic circular knee joint 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.). Two pairs of lateral spring stiffening ribs allow for moderate support of lateral displacement of the knee joint. The sealed silicone ring ensures fixation of the knee joint and the correct position of the patella, the reinforcing insert with tightening above and below the ring creates additional stabilization on the lateral and medial sides of the joint.

REABILITIMED TOV

Knee support orthosis
Primary Device ID04823097721612
NIH Device Record Keye1fe78c2-514c-470e-9f09-ee6bdd9c2ef9
Commercial Distribution StatusIn Commercial Distribution
Brand NameTM "Rehabilitimed" K-1P L Comfort
Version Model NumberK-1P L Comfort
Catalog NumberK-1P L 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
GS104823097721612 [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

04823097721872 - TM "Rehabilitimed" L-4M-3 S Comfort2025-05-26 Graphite-colored orthosis for the lumbar and sacral spine, used to stabilize the lumbosacral spine (Th10-S1). Equipped with 4 du
04823097721889 - TM "Rehabilitimed" L-4M-3 M Comfort2025-05-26 Graphite-colored orthosis for the lumbar and sacral spine, used to stabilize the lumbosacral spine (Th10-S1). Equipped with 4 du
04823097721896 - TM "Rehabilitimed" L-4M-3 L Comfort2025-05-26 Graphite-colored orthosis for the lumbar and sacral spine, used to stabilize the lumbosacral spine (Th10-S1). Equipped with 4 du
04823097721902 - TM "Rehabilitimed" L-4M-3 XL Comfort2025-05-26 Graphite-colored orthosis for the lumbar and sacral spine, used to stabilize the lumbosacral spine (Th10-S1). Equipped with 4 du
04823097721919 - TM "Rehabilitimed" L-4M-3 XXL Comfort2025-05-26 Graphite-colored orthosis for the lumbar and sacral spine, used to stabilize the lumbosacral spine (Th10-S1). Equipped with 4 du
04823097721926 - TM "Rehabilitimed" L-4M-3 XXXL Comfort2025-05-26 Graphite-colored orthosis for the lumbar and sacral spine, used to stabilize the lumbosacral spine (Th10-S1). Equipped with 4 du
04823097722053 - TM "Rehabilitimed" L-4M-3V S Comfort2025-05-26 Graphite-colored orthosis for the lumbar and sacral spine, used to stabilize the lumbosacral spine (Th9-S1). Equipped with 4 dur
04823097722060 - TM "Rehabilitimed" L-4M-3V M Comfort2025-05-26 Graphite-colored orthosis for the lumbar and sacral spine, used to stabilize the lumbosacral spine (Th10-S1). Equipped with 4 du
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.