Clinical Applications

Gel Ovations Medical Grade Silicone Dimensional Gel Pads have been used as a high risk pressure care solution since 2007. The products are widely implemented globally in healthcare settings in the UK, Europe, Canada, Japan and Australasia.

Safety Testing

Tested to exceed 260kg (40 stone) of loading

Compression testing by Independent Polymer Technology Limited, (ipolytech) (November 2021) using a Zwick 1474R universal test machine, with a laboratory temperature of 23+/- 2°C

Maximum load limitations of the Medical Grade Silicone Dimensional Gel Pad are made at 260kg, based on a safety factor of 6. A full sheet of Dimensional Gel (12” x 12”, 300mm x 300mm) comprising 149 cells can withstand 1.6 tons before being compressed to 4mm. The Gel Pads are 12.7mm thick.

The maximum user weight for a Bariatric chair is 260kg, or 40 stone. Based on the ipolytech data, the Gel Ovations pads will not fail under a user who is as heavy as the maximum user weight of a Bariatric Chair. The FDA Title 21 on Medical Devices (2021) states that medical devices must be able to withstand the rated load with an ‘appropriate factor of safety’.

Management Certification

ISO 9001:2015 Certified

Certificate number 377552021

MDR Approved

MDR Approved (Undertaken by the AdviQual Group, CEP073290719 Rev. [1.0], December 2020) Clinical Evaluation Report of the Dimensional & Flat Gel Pads, Gel Wheelchair & Mobility Accessories.

International Registrations

Registered by:

• MHRA
• EUDAMED
• CE Marked
• UK CA Marked

Declaration of Conformity

EU 2017/745, Annex IV

Gel Ovations declares under sole responsibility that Dimensional & Flat Gel Pads, Gel Wheelchair & Mobility Accessories meet the essential health and safety requirements as stated in Article V (Placing on the market and putting into service) and are in conformity with Annex IV European Parliament and of the Council Regulation.

Authorised Representative name: Crazy Grou (Ireland) Limited Registration number: IE-AR-000000093.

Manufacturing Statement

Gel Ovations Europe confirms that Gel Ovations Medical Grade Silicone Dimensional Gel Pads are designed and manufactured for the Prevention and Pressure Relief of Pressure Ulcers – Up to Grade 4, as part of a pressure care assessment and 24-hour care plan. Gel Ovations August 2022.

Report Copies are available on request by contacting in writing: info@gelovationseurope.com