Aging at home
The FDA puts these arms in its lowest-risk class (Class I), so they do not need FDA clearance before sale.
A dated step forward on the record
What the source says
“WMRA devices are classified by the FDA as a class I medical device and are exempt from the premarket notification process.”
What it means
Assistive robot arms, from Kinova, Assistive Innovations, 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.
Human help: Our sources report it working without human help.
More on Assistive robot arms
- Molina's policy treats these arms as unproven and does not count them as medically necessary, saying there is not enough research on long-term safety and benefit.
- US insurer Molina Healthcare names Kinova's Jaco and Assistive Innovations' iARM as the arms on the market today.
- The FDA rated the Jaco fire-risk correction as the most serious type of recall.
- California's Medi-Cal health plan began covering assistive robot arms as a benefit.
- Kinova sent all Jaco customers an urgent correction notice because a damaged outer coating on the arm could raise the risk of fire if it touches a wheelchair with an electrical fault. All lots were affected; no injuries or deaths were reported.
- More than 150 people in the Netherlands were feeding themselves with a Jaco arm.