All Spex Seating products are designed, tested, and manufactured within an ISO 13485-certified quality management system. For information on the specific standards and registrations applicable to a product, refer to the product documentation or contact us directly. 

Quality Management 

• ISO 13485:2016 — Medical devices — Quality management systems — Requirements for regulatory purposes 

Regulatory Registrations (applicable products) 

• European Union — Spex Limited manufactures Class I medical devices in accordance with the requirements of Regulation (EU) 2017/745 (MDR). Applicable devices are CE marked under the self-certification route, and Spex Limited has appointed an EU Authorised Representative. 

• United States — Spex Limited is registered with the FDA as a medical device manufacturer, and applicable devices are listed in accordance with 21 CFR Part 807. Devices are exempt from premarket notification [510(k)] requirements based on their classification. FDA registration and listing do not constitute FDA clearance or approval. 

Transport (applicable products) 

• ISO 16840-4:2009 — Wheelchair seating systems for use in motor vehicles 

• RESNA WC-4:2017, Section 20 — Wheelchair seating systems for use in motor vehicles 

Performance (applicable products) 

• ISO 21856:2022 — Assistive products — General requirements and test methods 

• ISO 16840-2:2018 — Wheelchair seating — Determination of physical and mechanical characteristics of seat cushions intended to manage tissue integrity 

• ISO 16840-3:2014 — Determination of static, impact and repetitive load strengths for postural support devices 

• ISO 16840-6:2015 — Wheelchair seating — Simulated use and determination of changes in properties of seat cushions 

Flammability (applicable products) 

• ISO 16840-10:2021 — Wheelchair seating — Resistance to ignition of postural support devices 

• California Technical Bulletin 117-2013 

• EN 1021-1:2014 and EN 1021-2:2014 — Furniture — Assessment of ignitability of upholstered furniture (smouldering cigarette / match flame equivalent) 

Reimbursement  (applicable products) 

• PDAC coding verification for USA Medicare/Medicaid reimbursement 

Transport Compliance — ISO 16840-4 and RESNA WC-4:2017, Section 20 

The Spex Seating System complies with ISO 16840-4:2009 and RESNA WC-4:2017, Section 20. The following products have been tested on the surrogate wheelchair frame defined by these standards: Back Support, Seat Base, Cushion, Arm and Thigh Supports, Lateral Trunk Supports, and Head Support. 

Back support height should be set to achieve maximum engagement with the scapula (shoulder blade), and a head support should be used when possible. 

Spex seating systems are designed for use with wheelchair bases that have been tested as part of a complete wheelchair system conforming to ISO 7176-19 (internationally) or RESNA WC-4:2017, Section 19 (US). The seating system is designed to be used when the wheelchair is facing forward in a motor vehicle. 

When installed on a conforming wheelchair base using Spex-approved mounting hardware, the complete system meets the requirements of the wheelchair transport standards. Spex-approved mounting hardware for specific wheelchair bases is identified on the relevant product pages. 

The wheelchair base must provide four securement points conforming to the relevant standard. A wheelchair tiedown and occupant restraint system (WTORS) conforming to ISO 10542-1 must be used during transport. 

Belt restraint accommodation – The Spex Seating System has been designed to accommodate the proper use of vehicle-anchored belt restraints. When tested in accordance with Annex C of RESNA WC-4:2017, Section 20 (and Annex D of ISO 16840-4) for accommodation of vehicle-anchored occupant restraints, Spex Seating achieved the following ratings: 

• Ease of properly positioning vehicle-anchored belt restraints on the wheelchair passenger: A (Good) 

• Degree to which proper positioning of belt restraints can be achieved: A (Good) 

• Overall score: 16 out of 16 

Postural support devices-  Any postural support device not intended for use as an occupant restraint — for example, a positioning harness or chest strap — should not be relied on for occupant protection in a vehicle crash. Postural belts should be positioned so they do not interfere with the proper positioning of vehicle-anchored belt restraints. Vehicle-anchored lap and shoulder belts remain the primary occupant protection system. 

Products not certified for transport- Back supports that sit lower than the user’s shoulder height are not certified for transport and are not recommended for use during vehicle travel. This includes Zygo Lo and Zygo Mid back supports. 

Spex Limited complies with the requirements of Regulation (EU) 2017/745 (Medical Devices Regulation).
Our Class I medical devices are assessed and declared compliant through a legally defined self-certification process permitted for low-risk devices under this regulation.
Applicable products carry the CE mark, and Spex Limited has appointed an EU Authorised Representative as required.

Spex Limited complies with applicable U.S. Food and Drug Administration (FDA) regulations for medical devices.
We are registered with the FDA as a medical device manufacturer, and our devices are listed in accordance with regulatory requirements (21 CFR Part 807).
Certain products are classified as low-risk devices and are exempt from premarket review (510(k)) requirements. FDA registration and listing do not constitute FDA clearance or approval