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.
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 Seniors Plus
Why are some Seniors Plus products Class I medical devices?
Celliant®
Fibre
Celliant® Fibre is a textile technology that converts body heat to infrared energy.
Celliant, manufactured by Hologenix and sponsored by Perform-Tex Australasia, is classed as a medical device in both Australia and New Zealand, and is included in Sleep Hive’s leading sleep systems and therapeutic chairs.
Celliant provides a range of scientifically validated benefits, including:
- Promoting local circulation
- Improving cellular oxygenation
- Increasing cell recovery speed
- Aiding thermoregulation
Whole Body Vibration
Whole Body Vibration therapy is a type of therapeutic massage.
Registered with the TGA as a class 1 medical device, Sleep Hive’s 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 assist in providing a number of benefits, including:
- Reduction in musculoskeletal pain
- Increase local area blood flow
- Assist joint mobilisation
- Improve sleep quality
Why is sleeping on a Class I medical device good?
Not everyone needs an adjustable bed enhanced with Celliant 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
CHOOSE WHAT SUITS YOU BEST
Which Seniors Plus products include Class I medical devices?
CELLIANT® bedding products are designated as Class 1 Medical Devices and have been notified on the Australian Register of Therapeutic Goods (ARTG) and the New Zealand Web Assisted Notification of Devices (WAND).
CELLIANT® Fibre is manufactured by Hologenix, LLC, 17383 Sunset Blvd Suite A420 Pacific Palisades, CA 90272, USA. Celliant® is a registered trademark of Hologenix, LLC. In Australia, Celliant® is sponsored by Perform-Tex Australasia, PO Box 1083, Hartwell, Victoria 3124, Australia. In New Zealand, Celliant® is sponsored by Perform-Tex Australasia, 75 Boston Road Mt Eden, Auckland 1023 PO Box 96016 Auckland 1342.
