Our therapeutic sleep systems are regulated as Class I medical devices. Here’s what you need to know.
FAQ
A Class I medical device is a classification of medical devices under the Therapeutic Goods Act 1989 (Cth).
Medical devices generally are defined as:
Other devices, which may be used for contraception or medical testing, are also classed as medical devices.
Medical devices are monitored by the Therapeutic Goods Administration (TGA), which certifies them as Class I, Class IIa, Class IIb, or Class III devices.
Class I devices are medical devices with a low risk to the user and the general public.
FAQ
Most of our sleep systems are designated as Class I medical devices because they incorporate whole-body vibration therapy.
Whole-body vibration therapy is a type of therapeutic massage.
Research suggests it may provide many different benefits, including:
FAQ
Not everyone needs an adjustable bed enhanced with vibration therapy to get the quality sleep they need.
But, for people who want to maintain independence and support their health, a therapeutic sleep system specifically designed to alleviate and compensate for injury or disability can make a big difference.
Importantly, every product registered as a medical device is continuously regulated by the TGA.
If you’re sleeping on a Class I medical device, you know that:
A manufacturer submits an application to have its medical device included in the ARTG.
If the application is successful, the TGA issues a certificate of inclusion and the device can be sold in Australia.
The manufacturer is required by law to abide by specific post-market responsibilities.
Range
Review our range of products and compare the inclusions and benefits to see what suits you best.
