CPAPNEA Medical Supply has a cleared 510(k) for the Optipillows EPAP mask for the sole intended use of alleviating snoring during sleep in adults, states the FDA in a warning letter.
Your device is misbranded under section 502(o) of the Act because you failed to submit a premarket notification as required by section 510(k) and 21 CFR 807.81(a)(3). Specifically, labeling found during FDA’s inspection shows that the Optipillows EPAP Mask is intended to treat obstructive sleep apnea, which is a major change or modification from the cleared intended use of the device requiring a new 510(k), including appropriate performance data in compliance with section 514 of the Act. The Optipillows EPAP Mask is also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because statements found in the device labeling are false or misleading because they claim the Optipillows EPAP Mask is as effective as CPAP devices at treating obstructive sleep apnea, suggest that the Optipillows EPAP Mask can be substituted for CPAP devices, and claim that FDA has clear EPAP technology for treating obstructive sleep apnea.