Power Plate International Ltd Certified as Medical Device Manufacturer

LONDON - Power Plate International Limited, the leader in Acceleration Training(TM) exercise equipment, today received certification as a Medical Device Manufacturer within the European Economic Area (EEA). This was granted to Power Plate International Limited by the British Standards Institute (BSI), a world leader in the field of Medical Device regulation.

Power Plate International Limited, while undergoing a rigorous audit process, also achieved full validation of its Quality Management System (QMS) and concurrently received ISO 13485 certification. Power Plate International Limited is the first specialised vibration exercise equipment manufacturer to have its full range of products certified as Medical Devices.

The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), acting as rapporteur for the EU, classified the full range of Power Plate(R) machines as class IIa Medical Devices.

Going forward, new Power Plate(R) machines will carry the CE mark, showing they meet all essential European health and safety requirements. The classification as a Medical Device also opens access for medical professionals to prescribe exercise on a Power Plate(R) machine as an additional treatment option for wide range of patient groups.

Auditors looked at every aspect of the company, from manufacturing processes and risk assessment through to order fulfilment, customer care, and warranty and after sales service.

“We are delighted to have achieved certification as a Medical Device Manufacturer. Not only does this offer new possibilities for therapy options, it also means all our customers can confidently expect to receive quality service in every area of our business,” says Mark Minter, President and COO of Power Plate International.

The certification process included a review of the efficacy and safety of the Power Plate(R) machine for use as part of a treatment regime to improve or alleviate various conditions.

This means healthcare professionals can potentially prescribe exercise on a Power Plate(R) machine as part of a wider treatment program to assist with the following conditions:

- Fall prevention - Improving muscular strength and power - Alleviating chronic pain - Reducing the appearance of cellulite - Aiding weight loss - Increasing bone density and preventing bone mineral density loss related to ageing - Improving circulation and cardiovascular function - Improving flexibility and range of motion - Improving general wellbeing, fitness and daily life functioning in patient populations

“We are looking forward to educating medical and healthcare professionals about the potential of exercise on Power Plate(R) machine to improve quality of life for a diverse range of people,” says Mr Minter.

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NOTES TO EDITORS:

About the Power Plate(R) machine

The Power Plate(R) machine is a leading international brand of whole body vibration equipment. It has been developed to optimise the effects of Acceleration Training(TM) exercise and offers a multitude of health and fitness benefits for a wide range of users, from athletes seeking to increase performance through to individuals wishing to improve their general health and fitness.

Just like traditional training, exercise on a Power Plate(R) machine uses the principle of Newton’s second law - force = mass x acceleration - to improve strength and power. However, rather than increasing mass, as when you lift weights, Acceleration Training(TM) exercise increases the second part of the equation, acceleration.

The muscles are stimulated to contract and reflex as the platform vibrates between 25 and 50 times per second. Acceleration Training(TM) exercise significantly reduces impact on joints, and increases the efficiency of your workout, saving you time and enhancing overall performance in as few as three short sessions each week.

Power Plate International Certified Medical Device Manufacturer

Power Plate International Limited is a certified Medical Device Manufacturer, conforming to ISO 13485, the recognised standard for organizations producing medical devices. Its full range of equipment is classified as class IIa Medical Devices by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

Power Plate(R) machines which carry the CE mark meets all essential European health and safety requirements. Healthcare professionals can now prescribe exercise on a Power Plate(R) machine as part of a wider treatment plan to assist with:

- Fall prevention - Improving muscular strength and power - Alleviating chronic pain - Reducing the appearance of cellulite - Aiding weight loss - Increasing bone density and preventing bone mineral density loss related to ageing - Improving circulation and cardiovascular function - Improving flexibility and range of motion - Improving general wellbeing, fitness and daily life functioning in patient populations Key Facts - The safety and efficacy of whole body vibration training is well documented and has been established through data from many studies.[1] - There are more than 25 independent published studies specifically using the Power Plate(R) machine, which investigate the effects of Acceleration Training(TM) exercise.[2]

About Power Plate International

Power Plate International Limited (PPI) is based in the United Kingdom, with a dedicated research and product development affiliate in the Netherlands. It manufactures and sells a leading brand of exercise training equipment within the whole body vibration training category. Through commonly owned subsidiaries and a network of distributors PPI has a presence in more than 90 countries.

1. Prisby, R.D., M-H Lafage-Proust, L. Malaval, A. Belli and L. Vico. Effects of whole body vibration on the skeleton and other organ systems in man and animal models. What we know and what we need to know. Ageing Research Reviews, Vol. 7 pp: 319-329. 2008

2. Power Plate International data on file

Source: Power Plate International Limited

Laura Nathan, Entice Communications, +44-208-959-3656,+44(0)7932-737-328