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

GUDID 04823097721490

The orthopedic device is graphite in color, has a dense structure, is an elastic circular knee joint orthosis made of aeroprene (aeroprene is a soft, breathable, highly elastic neoprene that has additional perforation holes on the entire surface that improve air and moisture exchange) with an insert made of a special mesh fabric under the knee, equipped with a relief limiting silicone ring around the hole for the patella, reinforced with two flexible spring stiffening ribs on the side surfaces and additional fixing straps.

REABILITIMED TOV

Knee support orthosis

• Primary Device ID: 04823097721490
• NIH Device Record Key: a31b0c7a-a2b1-4b66-8bd2-2844459d15e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TM "Rehabilitimed" K-1TM L Comfort
• Version Model Number: K-1TM L Comfort
• Catalog Number: K-1TM L Comfort
• Company DUNS: 364875768
• Company Name: REABILITIMED TOV
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 835 5030395
• Email: Krut.Lora@gmail.com
• Phone: 835 5030395
• Email: Krut.Lora@gmail.com
• Phone: 835 5030395
• Email: Krut.Lora@gmail.com
• Phone: 835 5030395
• Email: Krut.Lora@gmail.com
• Phone: 835 5030395
• Email: Krut.Lora@gmail.com
• Phone: 835 5030395
• Email: Krut.Lora@gmail.com
• Phone: 835 5030395
• Email: Krut.Lora@gmail.com
• Phone: 835 5030395
• Email: Krut.Lora@gmail.com
• Phone: 835 5030395
• Email: Krut.Lora@gmail.com
• Phone: 835 5030395
• Email: Krut.Lora@gmail.com
• Phone: 835 5030395
• Email: Krut.Lora@gmail.com
• Phone: 835 5030395
• Email: Krut.Lora@gmail.com
• Phone: 835 5030395
• Email: Krut.Lora@gmail.com
• Phone: 835 5030395
• Email: Krut.Lora@gmail.com
• Phone: 835 5030395
• Email: Krut.Lora@gmail.com
• Phone: 835 5030395
• Email: Krut.Lora@gmail.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04823097721490 [Primary]

FDA Product Code

• ITM: Cage, Knee

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-12
• Device Publish Date: 2025-05-04

Devices Manufactured by REABILITIMED TOV

• 04823097721872 - TM "Rehabilitimed" L-4M-3 S Comfort: 2025-05-26 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 Comfort: 2025-05-26 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 Comfort: 2025-05-26 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 Comfort: 2025-05-26 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 Comfort: 2025-05-26 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 Comfort: 2025-05-26 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 Comfort: 2025-05-26 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 Comfort: 2025-05-26 Graphite-colored orthosis for the lumbar and sacral spine, used to stabilize the lumbosacral spine (Th10-S1). Equipped with 4 du