Compress, hot/cold pack, reusable (Cancelled under s.41GN(1)(f))
Product name
Compress, hot/cold pack, reusable
Sponsor
ARTG
185076
Date action takes effect
Compliance action
Medical device cancellation
Type of action
Cancelled under s.41GN(1)(f)
Grounds for regulatory action
As the device labelling did not comply with the essential principles, the certification made under s.41FD (d) was incorrect.As the sponsor failed to provide evidence that conformity assessment procedure has been applied to the device, the certifications made under s.41FD(f) and (g) were incorrect.As the promotional material did not comply with the Therapeutic Goods Advertising Code 2007, the certification made under s.41FD(h) was incorrect.