DEVICE: TM "Rehabilitimed" K-1PS M (04823097706022)
Device Identifier (DI) Information
TM "Rehabilitimed" K-1PS M
K-1PS M
In Commercial Distribution
K-1PS M
REABILITIMED TOV
K-1PS M
In Commercial Distribution
K-1PS M
REABILITIMED TOV
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.
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? |
---|---|---|---|---|
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 [?] |
---|---|
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 |
---|
Device Size Text, specify: Mid-knee circumference in standing position (cm): 34-37 |
Device Record Status
2cfe0d22-0095-4862-ad3b-4d9c39f2f52f
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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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