Strutt ev¹c
Certifications and approvals
The regulatory paperwork behind the Strutt ev¹c, in one place. If you are an occupational therapist, a plan manager or a funding body checking what the machine is registered as, this is what you need.
Download the documents
The certificates themselves, ready to attach to a funding application or send to an occupational therapist. Both save straight to your device.
Need something else for a funding application? Tell us what the funding body has asked for and we will send it through, usually the same day.
Australian Register of Therapeutic Goods
The Strutt ev¹c is included on the Australian Register of Therapeutic Goods as an electric-motor-driven, occupant-controlled wheelchair. The sponsor of the entry is Sungo Australia Pty Ltd, the Australian sponsor for Strutt. Key to Independence is the exclusive Victorian distributor, not the sponsor.
- ARTG identifier
- 527659
- Start date
- 12 June 2026
- Sponsor
- Sungo Australia Pty Ltd
- Product category
- Medical Device Included Class 1
- GMDN code
- 41875
- GMDN term
- Electric-motor-driven wheelchair, occupant-controlled
You can confirm any of this yourself by searching identifier 527659 on the Therapeutic Goods Administration’s public ARTG search. No specific conditions have been recorded against the entry.
European declaration of conformity
Strutt also hold a CE declaration of conformity for the ev¹c and ev¹e under the European Medical Device Regulation. This is a European document rather than an Australian approval, and we list it because it names the standards the machine was assessed against.
- Regulation
- EU 2017/745, Medical Device Regulation
- Classification
- Class I, Rule 13, Annex VIII
- Assessment route
- Annex II and III
- Manufacturer
- Shenzhen Ruochuang Intelligent Manufacturing Co Ltd
- EU representative
- SUNGO Europe B.V., Netherlands
- Basic UDI-DI
- 698022680SEVS7
- EMDN
- Y1299
- File reference
- MDR-TCF-001-08
Standards assessed against
The declaration lists the harmonised standards applied. ISO stands for the International Organization for Standardization, and the ISO 7176 series is the international standard set for wheelchairs, covering everything from static stability and braking to climatic testing and power and control systems.
- ISO 7176 parts 1 to 5, 6, 7, 8, 9, 10, 11, 13, 14, 15, 21, 22 and 31, covering wheelchair stability, brakes, dimensions, energy consumption, impact and fatigue strength, climatic testing, power and control systems, and electromagnetic compatibility
- EN ISO 14971:2019+A11:2021, application of risk management to medical devices
- EN ISO 15223-1:2021+A1:2025, symbols used with medical device labels
- EN ISO 20417:2026, information supplied by the manufacturer
- EN ISO 10993 parts 1, 5, 10 and 23, biological evaluation of materials that touch the skin
- EN 60601-1-2:2015+A1:2021 and EN 12184:2022, electromagnetic compatibility and electrically powered wheelchairs and scooters
- EN ISO 16840-10:2021/Amd1:2024, wheelchair seating
Read the documents themselves: the ARTG certificate (PDF, 880KB, opens in a new tab) and the European declaration of conformity (image, 309KB, opens in a new tab).
Need the paperwork for a funding application?
Tell us what the funding body has asked for and we will send the documents through, usually the same day.