FDA WARNING_LETTER - Inno Health Technology, Inc.

The FDA issued a Warning Letter to Inno-Health Technology, Co., Ltd. after discovering the firm was marketing its Electro-Acupuncture ACULIFE device in the U.S. without proper marketing clearance or approval. An FDA review of the company's website on November 1, 2010, revealed promotional claims for the ACULIFE device, such as improving blood circulation, speeding up metabolism, preventing various diseases, and enhancing immunity. These claims represent a major change in the device's intended use, requiring a new premarket notification under 21 CFR 807.81(a)(3)(ii). Consequently, the device is deemed adulterated under Section 510(f)(1)(B) of the Act for lacking an approved PMA or IDE, and misbranded under Section 502(o) of the Act for failure to submit a 510(k) notification for these new uses. Furthermore, promotional claims suggesting the device is suitable for the whole family imply over-the-counter use, which is not part of its cleared indications. The device is also misbranded under Section 501(a) of the Act because its labeling falsely uses the FDA logo and suggests FDA approval for unapproved uses. The FDA demands immediate cessation of marketing for unapproved uses and prompt corrective actions within fifteen working days, warning of potential regulatory actions including seizure, injunction, civil money penalties, and refusal of admission into the U.S. if violations are not corrected.