Foot adapter 2C8=M8

Dénomination commerciale

Foot adapter 2C8=M8

04820304200212

482030420FOOTTHREADZ5

Numéro de référence/catalogue

Foot adapter 2C8=M8

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 2C8=M8 foot adapter is a lower-limb prosthetic component intended for use with a SACH-type foot. It connects the prosthetic foot to the tubular section of the prosthesis and helps ensure proper alignment of the assembly. The device is intended exclusively for external lower-limb prosthetic applications. It is recommended for mobility level 1 (indoor walking) and mobility level 2 (limited outdoor walking). The maximum permitted body weight is 125 kg. The proximal connection is designed as an adjustment pyramid, while the distal connection is an M8 screw.

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, including an appropriate SACH-type foot. Incorrect assembly, insufficient tightening, incompatible components, or improper alignment may cause instability, component failure, or falls. Do not use the device if it is 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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