FDA WARNING_LETTER - Acu International - September 25, 2012

Acu-International Supplies, Inc. received a Warning Letter from the FDA for marketing its Electro Meridian Imaging (EMI) device without required marketing clearance or approval. The FDA reviewed the firm's website and determined the EMI device, an accessory to Class 2 acupuncture needles, is a medical device intended for diagnosis and treatment, thus requiring 510(k) clearance. The device is deemed adulterated under section 501(f)(1)(B) of the Act due to the lack of an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE) application. Furthermore, the device is misbranded under section 502(o) because the firm failed to submit a 510(k) notification for commercial distribution. Additionally, the firm failed to fulfill annual establishment registration and device listing requirements for fiscal year 2012, rendering all its devices misbranded under section 502(o) for not being manufactured in a duly registered establishment and not being included in the required device list. Acu-International must promptly correct these violations and respond to the FDA within fifteen business days with specific corrective actions, a prevention plan, and a timetable for completion to avoid further regulatory actions such as seizure, injunction, or civil money penalties.