FDA Refusing Imports of Danish Company's Wheelchairs and Standing Frames
The Food and Drug Administration is refusing imports of wheelchairs and standing frames from Danish device company R82 A/S for violations of current good manufacturing practice requirements, according to a warning letter dated Oct. 18. The letter said entry will…
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be refused for the following R82 products, “given the serious nature of the violations”: the Cougar wheelchair, the Panther wheelchair, the Cheetah wheelchair, the Flamingo wheelchair, the Stingray mechanical chair, the Tiger 2000 mechanical chair, the Serval mechanical chair, the Wombat chair, the Nandu chair, the Swan bath chair, the Manatee bath chair, the Rabbit mobile standing frame, the Buffalo standing frame, the Gazelle standing frame, and the Toucan standing frame. The import alert won’t be lifted until the violations are corrected, FDA said.