Elitac Wearables’ BalanceBelt Registered as EU Class 1 Device

Elitac Wearables has registered its BalanceBelt as a Class 1 medical device — a designation for devices that are low- to medium-risk — under the EU’s Medical Device Regulation.

The device is a wearable treatment for patients with severe balance disorders, specifically those with bilateral vestibular hypofunction or loss. Worn around the waist, the belt offers patients haptic (touch) feedback to improve the perception of their body position.

The disorders, in which the balance organs in both ears are either impaired or completely nonfunctional, did not previously have any sustainable, noninvasive treatment options, the company says.