Class 1 Medical Devices
What Is a Class I Medical Device?
A Class I medical device is a classification of medical devices under the Therapeutic Goods Act 1989 (Cth).
Medical devices generally are defined as:
Being intended for human use, for:
- the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease; or
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability.
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, Class III, or AIMD devices. Class I devices are medical devices with a low risk to the user and the general public.
Why Are Some Seniors Plus Products Class I Medical Devices?
Most of our products are designated as Class I medical devices because they incorporate whole-body vibration therapy.
Whole-body vibration therapy is a type of therapeutic massage.
Registered with the TGA as a Class 1 medical device, Seniors Plus’ whole-body vibration therapy uses a generated mechanical stimulus to activate muscle spindles, and is included in our sleep systems and therapeutic chairs.
Whole-body vibration may provide a number of benefits, including:
- Reducing musculoskeletal pain
- Increasing local blood flow
- Assisting joint mobilisation
- Improving sleep quality
Why Is Sleeping on a Class I Medical Device Good?
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 prevent injury, or those who already live with discomfort or sleep disorders, 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.
TGA Regulation Stages
- Pre-market assessment, when the TGA assesses manufacturing processes and the device itself for quality, safety and performance compliance
- Market authorisation, when the device is officially entered into the ARTG
- Post-market monitoring, when the TGA monitors the device over its market lifespan, assessing its performance and compliance with safety standards
If you’re sleeping on a Class I medical device, you know that:
- An independent government body (the TGA) recognises it as a valid medical device.
- That same body continually monitors it for safety and quality.
Which Seniors Plus Products Include Class I Medical Devices?
Review our range of products and compare the inclusions and benefits to see what suits you best.
