FDA WARNING_LETTER - Pneumex, Incorporated - July 29, 2008

The FDA issued a Warning Letter to Mr. Cook following an inspection from July 28-29, 2008, at 2605 N Boyer Avenue, Sandpoint, Idaho. The firm manufactures medical devices including Pneu-MAP, Pneu-Back Chair, Pneu-Weight, Pneu-Lift, Pneu-Walker, Pneu-Vibe, Plinth Vibration table, and Vibro Trac table.

The Pneu-MAP and Pneu-Back Chair were found to be adulterated under section 501(f)(1)(B) of the Act because the firm lacked an approved premarket approval (PMA) or investigational device exemption (IDE) application. They were also misbranded under section 502(o) for failure to submit a 510(k) premarket notification. Although these devices are generally exempt from premarket notification, their labeling for scoliosis diagnosis (Pneu-MAP) and treatment (Pneu-Back Chair) constitutes a different intended use from legally marketed devices in their generic types (21 CFR 890.1600 and 890.1925, respectively), thus requiring a 510(k) submission per 21 CFR 890.9.

All manufactured devices were found to be adulterated under section 501(h) due to non-conformity with