Unapproved Wheelchair Cushions Top Multi-Issue Warning Letter

A Tennessee maker of wheelchair components received an FDA warning letter after the agency determined some products advertised on the company’s website had never been formally approved. The July 27 letter, issued by the FDA’s New Orleans District Office, cited Hendersonville-based AireRx Healthcare with nine violations, including the company’s online promotion of wheelchair cushions described as reducing causes of skin tissue trauma. The product was never cleared via PMA or investigational device exemption, which is required for wheelchair components carrying specific health claims, the FDA district director wrote.
Devices & Diagnostics Letter