POWERED WHEELCHAIRS MUST PROVIDE EMI WARNINGS
This article was originally published in The Gray Sheet
Executive Summary
POWERED WHEELCHAIRS MUST PROVIDE EMI WARNINGS, FDA says in a recent letter to manufacturers of powered wheelchairs, scooters and components or accessories for the devices. The labeling, which must be affixed to devices shipped after Dec. 2, should include an explanation of electromagnetic interference, how to avoid risks associated with it, warnings that accessories or components may compound risks associated with EMI, and statements detailing the level of the device's immunity to EMI, according to the letter. For products already on the market, FDA says the information should be "supplied to consumers as soon as it is feasible."