FDA WARNING_LETTER - CPAPNEA Medical Supply - July 30, 2019

On July 18, 25, and 30, 2019, an FDA inspection of CPAPNEA Medical Supply in Phoenix, AZ, revealed that the firm manufactures the Optipillows EPAP mask. The FDA determined the device is adulterated and misbranded.

The Optipillows EPAP mask is adulterated under section 501(f)(1)(B) of the Act because the firm lacks an approved premarket approval (PMA) application for the device as marketed. It is misbranded under section 502(o) for failure to submit a premarket notification (510(k)) for changes to its intended use, and under section 502(a) due to false or misleading labeling.

The firm has a cleared 510(k) (K181219) for the Optipillows EPAP mask solely for alleviating snoring. However, the firm's website and labeling market the device to treat obstructive sleep apnea and as a substitute for CPAP devices, which is beyond its cleared indications. This constitutes a major change requiring a new 510(k). The labeling also falsely claims the Optipillows EPAP mask is as effective as CPAP devices for treating obstructive sleep apnea and that FDA has cleared EPAP technology for this purpose, raising public health concerns as no supporting evidence has been provided.

The inspection also found the