FDA WARNING_LETTER - HoMedics, Incorporated - August 30, 2007

The FDA issued a Warning Letter to HoMedics, Inc. on June 16, 2008, following an inspection of their Dongguan, China facility from August 27-30, 2007. The letter identifies significant violations related to marketing clearance and Quality System (QS) regulation.

HoMedics is marketing the TheraP® Deluxe Automatic Blood Pressure Monitor and Therapist Select® Massagers (with infrared heating) in the U.S. without required marketing clearance or approval. The TheraP® monitor's claim "Irregular Heartbeat Detector" constitutes a new intended use, requiring a new 510(k) submission (21 CFR § 807.81(a)(3)), making the device misbranded (Section 502(o)) and adulterated (Section 501(f)(1)(B)). The Therapist Select® Massagers are also adulterated and misbranded for lacking marketing clearance, as infrared heating devices require a 510(k) (21 CFR § 890.5500). HoMedics is instructed to immediately cease promotional claims for the TheraP® monitor.

The inspection revealed adulterated heating pads, paraffin baths, and blood pressure monitors due to non-conformity with CGMP requirements of the QS regulation (21 CFR Part 820). Violations include: 1. Failure