Socket adapter 4А31

Dénomination commerciale

Socket adapter 4А31

04820304200281

482030420SOCKETPYRAC

Numéro de référence/catalogue

Socket adapter 4А31

GS1

Classe I

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The 4A31 socket adapter is intended to connect the distal components of a lower-limb prosthesis to the residual-limb socket. The adapter allows angular adjustment of the distal or proximal components and enables axial alignment. The device is intended exclusively for external lower-limb prosthetic applications. It is recommended for mobility level 1 (indoor walking), mobility level 2 (limited outdoor walking), mobility level 3 (unrestricted outdoor walking), and mobility level 4 (unrestricted outdoor walking with particularly high demands). The maximum permitted body weight is 125 kg. The device connections consist of an adjustment pyramid and four M6 screws.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• Y062499LOWER EXTREMITY PROSTHESES - OTHER

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• Do not use the device for users weighing more than 125 kg or for mobility levels outside those specified by the manufacturer. The adapter must be installed, aligned, tightened, and inspected only by a qualified prosthetist and used exclusively with compatible prosthetic components. Incorrect assembly, insufficient screw engagement, inadequate tightening, incompatible components, or improper angular or axial adjustment may result in loosening, instability, component failure, or falls. Do not use the device if the adapter, adjustment pyramid, M6 screws, threaded connections, or connected components are cracked, deformed, corroded, loose, damaged, or excessively worn. Any unusual movement, noise, instability, pain, or change in prosthetic function requires immediate inspection by a qualified healthcare professional. The device must not be modified or used for any purpose other than lower-limb exoprosthetic fitting.

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