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4-point knee braces



For indications as
Osteoarthritis/valgus/varus (OA)
Post-traumatic/postoperative (OA, CI, GENU-Tex)
Pain relief in joint chambers (OA)
Partial/reconstructed ACL/PCL (CI, GENU-Tex)
Ligament rupture/instability (CI, GENU-Tex)
Drawer laxity in the knee (GENU-Tex)
Meniscus reconstruction (GENU-Tex)
Collateral ligament insufficiency (GENU-Tex)

Classification
06 12 09 01 - Knee orthoses

Documents



The product series contains 3 products.

Product 1 of 3
4-point knee brace - GENUDYN CI


HMI-no.
139303
Article-no.
7780

Registration date
11-12-2023
Last updated
14-12-2023

Properties
Intended for children
No
info
Products for children must comply with the specific demands for safety as stated in certain standards. It is the supplier of the product who has stated that the product is intended for children. The National Board of Social Services holds no responsibility in relation to this assessment.

Test information
No information about tests according to standards info
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation info
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device

Other specifications
Indications:
ACL/PCL lesions
Partial ligament rupture
Reconstructed ACL/PCL
Drawer laxity in knee
Collateral ligament rupture/insufficiency
Instability
Post-traumatic/postoperative
Severe instability


Product 2 of 3
4-point knee brace - GENU-TEX


HMI-no.
139304
Article-no.
7720

Registration date
11-12-2023
Last updated
14-12-2023

Properties
Intended for children
No
info
Products for children must comply with the specific demands for safety as stated in certain standards. It is the supplier of the product who has stated that the product is intended for children. The National Board of Social Services holds no responsibility in relation to this assessment.

Test information
No information about tests according to standards info
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation info
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device

Other specifications
Indications:
Instability
Osteoarthritis
Rheumatoid arthritis/RA
ACL rupture
Partial rupture
Reconstructed ACL
Drawer laxity in the knee
Meniscus reconstruction
Ligament rupture/insufficiency of collateral ligaments


Product 3 of 3
4-point knee brace GENUDYN CI NOVEL


HMI-no.
139277
Article-no.
7785

Registration date
04-12-2023
Last updated
14-12-2023

Properties
Intended for children
No
info
Products for children must comply with the specific demands for safety as stated in certain standards. It is the supplier of the product who has stated that the product is intended for children. The National Board of Social Services holds no responsibility in relation to this assessment.

Test information
No information about tests according to standards info
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation info
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device

Other specifications
Indications:
ACL and/or PCL rupture
Partial ruptures
Reconstructed ACL and/or PCL
Drawer laxity in the knee
Ligament rupture/insufficiency of collateral ligaments
Instability
Post-traumatic
Postoperative
Severe instability