Nom de l'organisation

MAD Adam Zdanowicz

SRN

PL-MF-000047582

Statut du fabricant

Actif

Marché principal en Pologne ; disponible dans 32 pays au total.

Dénomination commerciale

Ravy S - bicycle for people with dwarfism

Code d'IUD-ID

ID primaire

L'ID primaire est l'IUD-ID principal qu'un fabricant désigne comme identifiant de référence d'un dispositif dans EUDAMED.

05908453764010

IUD-ID de base

IUD-ID de base

L'IUD-ID de base est l'identifiant principal qui regroupe toutes les variantes d'un même modèle de dispositif — la clé de la « famille » réglementaire.

59084537640SML8T

Numéro de référence/catalogue

Ravy_S

Entité d'attribution

Entités d'attribution IUD

Les entités d'attribution sont les organismes que la Commission européenne a désignés pour attribuer les identifiants uniques des dispositifs au titre du système IUD de l'UE.

GS1

Catégorie de risque

Classes de risque MDR

Les classes de risque du MDR classent les dispositifs médicaux du risque le plus faible (classe I) au plus élevé (classe III), ce qui détermine le niveau de contrôle réglementaire.

Classe I

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The bicycle for little people was designed and manufactured by MAD Adam Zdanowicz as a result of the project No. POIR.02.03.02-20-0036/20 titled. “AchoBike - Bicycle for little people” subsidized under the Inteligent Development Operational Program, Priority Axis 2 - Supporting the environment and potential of enterprises to carry out R+D+I activities, Measure 2.3 Pro-innovative services for enterprises, Sub-measure 2.3.2 Innovation vouchers for SMEs. Bicycle prototypes were commissioned for special research at the Institute of Innovation and Technology of the Bialystok University of Technology in order to develop bicycles dedicated to little people (including those with various skeletal dysplasias). A specialized research team created the necessary technical and implementation documentation, as well as three variants of bicycles adapted to the three height ranges of people with significantly short stature. As a result of the research work, documentation was created to allow the implementation of bicycles dedicated to people with limited mobility and motor apparatus different from the recognized norm. An impact analysis of prototypes was carried out with the goal of health safety of little people. As a final result of the work, ergonomic prototypes of bicycles adapted to the needs of little people were created: 1.Adapted frame geometry to provide an ergonomic fit for the height, body proportions and physical capabilities of people with significantly short stature, 2.Special drive mechanism adapted to limited limb length, 3.Ergonomic solutions for saddle, pedals and steering improve stability and comfort The forementioned bicycles have a special design to alleviate the difficulties of little people, and are helpful in improving muscle strength, balance and motor function. Through the use of special propulsion mechanisms, stabilizers and unusual frame geometry, they support rehabilitation and improve the function of significantly short people.

URL des informations complémentaires

https://shortriders.com/en/

Dimensions cliniques

• for height up to 100cm (3ft 3,5in)

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel

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

• Y121801BICYCLES

• Dispositifs médicaux de Classe I dans EUDAMED

Aucun certificat ne référence l'IUD-ID de base de ce dispositif.