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ANKLE FOOT ORTHOSIS, standard, man, left

https://unicat.msf.org/cat/product/54092
STD EPHYAFOR1ML

Valid Article

Former Code(s): EPHYZFR0038 EPHYZNG0005
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
Y06120601 - Passive ankle-foot orthoses
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
I
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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ANKLE FOOT ORTHOSIS

Definition

An externally applied orthopaedic appliance used to encompass and support the ankle joint or the ankle. It prevents plantar flexion of the foot and is used for the treatment of drop foot.

Synonym

foot drop brace, foot drop splint, foot-up splint, foot lifter

Specifications

  • Prefabricated caliper/holder in polypropylene that fits around the back of the ankle joint and hold it in a 90° position (open orthosis)
  • 2 Velcro straps :
    • 1 around the shin (calf)
    • 1 across the front of the ankle
  • Can be comfortably and easily mounted in shoes
  • Different adult sizes according:
    • male: European 40-42 / American 7.5-9 / Large
    • female: European 37-39 / American 5.25-6.75/ Medium
  • left / right foot

MSF requirements

For people with paralysis of the muscles that lift the foot (of central or peripheral origin), to facilitate walking. In these cases the ankle/foot orthosis is used inside shoes.

For use in hospitals, health centres or at home or for a period of convalescence after a painful episode or surgery.

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