Under a settlement with the Federal Trade Commission, devicemaker NeuroMetrix has agreed to pay at least $4 million and stop making deceptive claims that its Quell transcutaneous electrical nerve stimulation device treats pain throughout the body when placed below the knee.

The order, filed in the U.S. District Court for the District of Massachusetts, bars NeuroMetrix from making such pain-relief claims unless they are true, not misleading, and supported by scientific evidence, and it prohibits misrepresentations about the scope of FDA clearance for any device.

NeuroMetrix marketed Quell nationwide, touting the device as “clinically proven” and “FDA cleared” for widespread chronic pain relief.

The Class II device was only cleared by the FDA for pain relief at the site of the pain.