Cleo Pads
All Cleo pad varieties are manufactured to medical grade standard
Cleo pads are produced in a globally esteemed and certificated production plant with the highest professionalism and rigorous attention to quality control and production and sustainable operation.
Optimized for precise stimulation and enhanced results, Cleo pads are made using a 3 layer process comprising hydrogel, conductive carbon and a fabric backing layer, Cleo pads have a resistance under 50 Ohms.
Hydrogel is a biphasic material, a mixture of porous, permeable solids and at least 10% by weight or volume of interstitial fluid composed completely or mainly by water.
Our manufacturers ethos
1. Unparalleled Expertise: with almost 30 years of experience in electrode manufacturing, our team of skilled professionals brings a wealth of knowledge and expertise to every product we create. We understand the intricate nuances of electrode design, ensuring that each product meets the highest standards of quality and functionality.
2. Cutting-Edge Technology: we stay at the forefront of technological advancements, utilizing the latest materials and manufacturing techniques to develop electrodes that exceed expectations. Our dedication to continuous improvement enables us to provide products that are not only effective but also innovative.
3. Quality Assurance: quality is the cornerstone of our manufacturing process. Our electrodes undergo rigorous testing and quality control procedures to ensure they perform consistently and reliably.
Cleo pads are produced with the following certification
FDA 510K: a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective.
CE: marking indicating that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements.
ISO 13485 2016: specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
GMP: refers to the Good Manufacturing Practice regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act. These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This protects the consumer from purchasing a product which is not effective or even dangerous.
Cleo pad features
- Conductive surface made of carbon sheet
- Lead wire design
- Soft and highly flexible
- Negative cytoxicity (cytotoxicity is the degree to which a substance can cause damage to a cell)
- Negative skin sensitization (skin sensitization is the regulatory hazard known as allergic contact dermatitis or ACD)
- Negative acute cutaneous irritation (defined as a nonimmunological inflammatory reaction skin to an external agent)