Aging at home
PARO was listed with the US FDA as a Class II medical device that is exempt from premarket review. That means it did not need an FDA clearance before sale.
A dated step forward on the record · Company-reported
What the source says
“Class II exempt pre-marketing notification from the Food and Drug Administration (FDA)”
What it means
PARO, from PARO Robots (Intelligent System Co.), is at stage 4 of 5 on our ladder: paying customers. Its stage is set by other milestones on its record; this one adds to the history. This line rests on the company's own announcement; no regulator, customer or independent report confirms it in our sources yet.
Human help: Our sources report it working without human help.
More on PARO
- The US government's medical device database lists PARO under the FDA product code for biofeedback devices, marked as exempt from premarket submission.
- A University of Brighton team tested PARO's hygiene and cleaning for nine months on a dementia ward run by Sussex Partnership NHS Foundation Trust in England.
- AARP reported that some care facilities were using PARO to calm residents with dementia.
- PARO went on sale in the United States to individuals and institutions, at $6,000.
- PARO, designed by Dr Takanori Shibata at Japan's national research institute AIST, went on sale in Japan in 2005.