AireRx Healthcare, LLC – FDA Warning Letter, Apr 13, 2012

This FDA Warning Letter (2012-NOL-27) was issued to AireRx Healthcare, LLC, following an inspection from April 9-13, 2012, at their Hendersonville, Tennessee facility, which manufactures wheelchair cushions. The FDA determined these products are medical devices.

The "Cool-Comfort wheelchair cushions" are adulterated under Section 501(f)(1)(B) of the Act because AireRx lacks an approved Premarket Approval (PMA) application or an Investigational Device Exemption. They are also misbranded under Section 502(o) for failing to submit a premarket notification (510(k)) as required, specifically because claims like "reduce heat, moisture and shear" exceed the wheelchair component classification.

The inspection also revealed the devices are adulterated under Section 501(h) due to non-conformity with Quality System (QS) regulation (21 CFR 820). Violations include: 1. Failure to establish adequate complaint handling procedures (21 CFR 820.198(a)), including review for Medical Device Reporting (MDR) events. 2. Failure to document reasons for not investigating complaints (21 CFR 820.198(b)). 3. Failure to control nonconforming product (21 CFR 820.90(a)).