Socket adapter PCA01

Dénomination commerciale

Socket adapter PCA01

04820304200564

482030420PANTHERSOCKETUY

Numéro de référence/catalogue

Socket adapter PCA01

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 PCA01 socket adapter is intended for the permanent mechanical attachment of the PANTHER prosthetic foot for strength sports to the residual-limb socket when using an externally mounted adapter configuration. The adapter provides a secure connection between the residual-limb socket and the prosthetic foot, transfers loads during standing, walking, and sports activities, and allows precise positioning of the prosthetic components according to the user’s individual needs. The device is intended exclusively for external lower-limb prosthetic applications. It is recommended for 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 proximal connection consists of M6 threaded holes, while the distal connection consists of two M8 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

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• 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, positioned, tightened, and inspected only by a qualified prosthetist and used exclusively with the compatible PANTHER prosthetic foot and approved prosthetic components. Incorrect assembly, insufficient thread engagement, inadequate tightening, improper positioning, or use with incompatible components may result in loosening, instability, structural failure, or falls. Do not use the device if the adapter, M6 threaded holes, M8 screws, fastening elements, or connected components are cracked, deformed, corroded, loose, damaged, or excessively worn. Any unusual movement, noise, instability, pain, loss of performance, 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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