DEVICE: TM "Rehabilitimed" K-1P XL Comfort (04823097721629)
Device Identifier (DI) Information
TM "Rehabilitimed" K-1P XL Comfort
K-1P XL Comfort
In Commercial Distribution
K-1P XL Comfort
REABILITIMED TOV
K-1P XL Comfort
In Commercial Distribution
K-1P XL Comfort
REABILITIMED TOV
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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41065 | Knee support orthosis |
A stand-alone prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the knee; it may incorporate hinges for improved support. It is not a component of a larger device assembly. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ITM | Cage, Knee |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Mid-knee circumference in standing position (cm): 42-45 |
Device Record Status
35866c61-6cd4-49e8-85c4-de18d025eab7
May 12, 2025
1
May 04, 2025
May 12, 2025
1
May 04, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
835 5030395
Krut.Lora@gmail.com +380965139983
shenyalipinskiy@gmail.com +380937042825
reabilitimed@ukr.net
Krut.Lora@gmail.com +380965139983
shenyalipinskiy@gmail.com +380937042825
reabilitimed@ukr.net