FinCCHTA

Kansallinen HTA-koordinaatioyksikkö FinCCHTA
PL 10, 90029 OYS

fincchta@ppshp.fi

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Indego® exoskeleton walking robot

Valid to: 06.2023

Information about the product

The Indego® exoskeleton is a wearable walking robot that allows a fully or partially paralyzed person to walk in various environments. The product has two options: Indego Therapy for rehabilitation and Indego Personal for private use. This assessment is for Indego Therapy.1

The device has FDA approval and a CE mark. The device is a class IIa medical device (Medical Device Directive [MDD] 93/42/EEC).1

The manufacturer of the product is Parker Hannifin Corporation, and the distributor in Finland is Fysioline Oy.1 The company uses the ISO 13485:2016 quality management system.1

Additional information

Language
  • Finnish
Certificates
  • Medical Device, level II a MDD
  • US FDA, Class II
Quality control
  • ISO 13485
  • Other

Conclusion 16.6.2020

The product meets the assessment criteria partially

The device is suitable for use in conjunction with other rehabilitation methods. The use of the device requires sufficient upper extremity strength to manipulate a stability aid, and the rehabilitator should be continuously present.

Research evidence on the benefits of the device is scarce.

The assessment is based on the information provided by the company.

Assessment fields

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