ATALANTE Intended use - Wandercraft


ATALANTE Intended use

Atalante is CE marked in Europe according to the following intended use:

  • The Atalante system is intended to perform ambulatory functions, mobility exercises and adapted physical exercises, hands-free, for individuals having lower limb and trunk disability in rehabilitation centers, city cabinets or adapted physical exercise centers under the supervision of trained operators.
  • The Atalante system is not intended for non-adapted sports, aggressive use, stair climbing or usage in other outside premises.

Class of device
Class IIa medical device [Annex VIII, Medical Device Regulation 2017/745]

CE 2797

List of safety and performance standards

are technical specification, approved by a certification body, where its implementation is not mandatory. It attests the compliance of a product/service/process/system to a set of requirements. Applicable standards to medical devices and particularly to Wandercraft medical devices are the following (non-exhaustive list):

- EN ISO 13485 : 2016 - Medical devices – Quality management systems – Requirements for regulatory purposes
- EN ISO 14971 : 2019 - Medical devices – Application of risk management to medical devices
- EN 60601-1 : 2006 - Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- EN 60601-1-2:2015 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and test
- EN ISO 10993-1:2018 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- IEC 80601-2-78:2019 Medical electrical equipment -- Part 2-78: Particular requirements for the basic safety and essential performance of medical robots for rehabilitation, compensation or alleviation of disease, injury or disability
- EN 62304 : 2006 - Medical device software – Software life cycle processes
Date of last update: 01/07/2021

Join the revolution

You wish to upgrade your facility with Atalante?
Contact us. We will be happy to call you back.

+33 (0)9 72 58 77 05

88 rue de Rivoli-75004 PARIS

Monday to Friday

from 8:30 am to 6:00 pm

Copyright 2020, Wandercraft