I wonder what factors led to this… Because the company was incorporated in California? Was there a complaint? News story catch the eye of someone at the DCPH? Have other manufacturers seen this and as a result done things differently? From June of 2013.
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.