The California Department of Public Health (CDPH) today warned consumers not to use the unapproved medical device sold on the Internet as a TDCS (Transcranial Direct Current Stimulation) Home Device Kit.
TDCS Device Kit, Inc. of Petaluma, Calif., is voluntarily recalling the TDCS Home Device Kits because the product has not been federally approved to market in the United States, and has not been determined to be safe and effective for their intended use. During a recent inspection, CDPH determined that the devices had not been manufactured in compliance with good manufacturing practices for medical devices. Also, the devices were found to be labeled without adequate directions for use and without adequate warnings against uses that may be dangerous to health.
Use of the device could pose a health risk including, but not limited to: epileptic seizures, cardiac arrhythmias, cardiac arrest, optic and otic nerve injuries, skin irritation, headaches, blurred vision, and dizziness. No illnesses or injuries have been reported at this time.
Recalled TDCS Device Kits were manufactured and distributed worldwide from November 2012 through April 2013. The devices have no identifying control numbers (e.g.: lot codes, serial numbers, or production dates) printed either on the packaging, or the units themselves, but would have been received by mail from TDCS Device Kit, Inc.
Consumers with questions may contact the company via telephone at (707) 477-8930 between the hours of 10 a.m. to 4 p.m. Pacific Standard Time. Consumers may also contact the company via e-mail at firstname.lastname@example.org.
Consumers who have experienced any injury or illness associated with the use of this product should contact their health care provider.