These electrical stimulation devices deliver an electrical shock through electrodes on a user’s skin. According to the FDA, evidence links such devices to psychological and physical risks, including depression, anxiety, worsening of self-injury behaviors, pain, burns, tissue damage and errant shocks from a malfunctioning device.
The FDA says such devices present an “unreasonable and substantial risk to public health,” and the risk cannot be eliminated by just correcting or updating a label.
“Our primary concern is the safety and well-being of the individuals who are exposed to these devices,” William Maisel, MD, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in a statement. “These devices are dangerous and a risk to public health — and we believe they should not be used.”
The FDA seeks comments on the proposed rule.
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